This page was created for ALS patients, families and anyone wanting to gain knowledge on this study.
I will share my experience through this study trial for those who may also be considering participation in the study. Keep in mind; this information should not be used to base your decision. Every case is different and should be considered on an individual basis.
In July 2010, the Ceftriaxone research study trial was introduced to me during my clinic visit at St. Louis University ALS clinic. Living with this disease, four factors have to be considered; 1) a quality of life change, 2) the side effects from Ceftriaxone, 3) my own personal time I would have to sacrifice, 4) knowing this is a random study. A random study is 2/3 of the participants receive the drug Ceftriaxone and the other 1/3 receive placebo. No one knows who receives which other than the pharmacist setting up the drug.
One huge change would be to wear a central venous catheter for the rest of my life. This would be something I would have to adjust to. It is not like I would be able to take it off as I can a leg brace. I also had to keep in mind the others this was going to affect by my being involved. My wife will be the person administering the drug. This drug is administered twice/day. The dressing that covers the area where the catheter exits has to be changed minimum of once a week.
Side effects also need to be considered. One possibility is Ceftriaxone causing development of gall stones. Although there is a drug I will be required to take twice/day to reduce this risk, there still is a slight chance of development. If gall stones do occur, I will be removed from the study.
Infections could occur from the placement of the catheter. Other infections can develop as well. All this is reviewed and explained with my wife and me as we reviewed the consent forms.
Precious time was another factor I had to consider involving myself in this study. Going to my scheduled regular clinical visits are every 3 months. This is something my wife and I do not look forward to. The reality of fear grows in us to learn the possibility that my condition has worsened through the assessments they perform. Now I have to consider going more often by adding the study visits into my life schedule.
Knowing this is a random study, I had mixed feelings. At one point, I did not want to participate there is a chance of receiving the placebo. After a long decision period I came to the conclusion my chances were better getting Ceftriaxone than not.
My wife and I discussed all the concerns. From the moment this was introduced, my wife urged me to move forward. Move forward? Move forward by getting involved. A decision I have to make involving these factors was not easily made. Since there is no cure on the horizon, I had to keep in mind this was the next best thing. What has eased me through this process is my research nurse, Anne Fann. Anne has listened to all of my concerns and has made the commitment of being there all the way through the study process. My doctor, Dr. Ghazala Hayat, has been very proactive in encouraging me to take part in this study. I could tell by her reaction she was pleased to hear I was going to participate in the study. I am grateful since there are many doctors that may tell you to go home and have a good life. My wife explained if this is the next best thing my doctor can offer since there is no cure, and then why not participate?
I sometimes like to refer to my favorite quote from President John F. Kennedy- “There are those who look at things the way they are, and ask why…I dream of things that never were and ask why not?”
January 13, 2011 Screening Visit
The purpose of this visit is to find out if I meet all the requirements to participate in this study. A number of procedures took place during my visit. The projected time through this process was to be 2 hours, actual time was 5 hours. I was not a happy camper for I did not view this as quality time.
Vital Capacity testing: A test that measured the amount of air I could exhale following a deep breath. I held a mouthpiece in my mouth, inhaled deeply, followed by an exhale as long and hard as I could produce. Numbers are recorded for the purpose of starting a baseline. I am not sure there is a normal number for this is used as a starting point.
ALS Functional Rating Scale: A questionnaire consisting of 12 questions regarding my ability to function and perform certain daily activities. My wife (my caregiver) and I filled out a questionnaire pertaining to my quality of life. These questions needed to be answered as honestly as possible. The answers are based on a rating scale of 1-10, 10 being very important down to 1 being least important. Example: Is having people around you daily important to you? Some questions required time to really think in order to produce an honest answer.
ALS –Specific Quality of Life questionnaire and Caregiver Burden Inventory: My wife (my caregiver) and I filled out a questionnaire pertaining to my quality of life. The rating scale is from very important to least is required for my answer.
Strength Testing: This is a test that measures my muscle strength in my arms and legs. A device used (dynamometer) is held by the coordinator and pushes against my arms and legs while I try and hold against the pushing. I felt frustrated with some of these tests. You take for granted to lifting up your foot and soon discover how something so simple has become difficult.
Abdominal Ultrasound: Since there is a low risk of gall stones to develop from this drug, an ultrasound is done on the gallbladder to make sure it is in good shape.
Written informed consent
Assessment of inclusion and exclusion criteria
Review of my medical history
Complete medical exam
My vital signs checked (Blood pressure, Heart and respiratory rates and temperature) and weight
Review of my current medications
My research nurse will call me in one week to tell me if I am able to take part in the study. I will be asked to return within 26 days of the screening visit to have the central venous catheter placed. This day will last 6 hours. Seeing a catheter on a “dummy” gave me a sense of reality. The catheter is placed under my skin from my neck area down to my breast area. The catheter will exit at this point and approximately 12 inches will hang out. Once the procedure is done, I will recover and then the first dose of the drug will be administered. A waiting period of 3 hours is required to make sure no immediate effects arise. There are 4 visits required the first month after the placement of the catheter. The purpose for these visits is to check for infections on the site of the catheter.
By the fourth visit and every 16 weeks thereafter, all the tests performed at the screening visit are repeated.
A monthly visit will be required from me to check for various things depending on the visit schedule.
January 20, 2011 Passed Pre-Screening
I received a call from my research nurse informing me that I made it through the pre-screening stage. This clears the way to enter into the Ceftriaxone Trial study set to begin on February 3, 2011. Again, the purpose of the pre-screening is to make sure I meet the study requirements. I will admit I am a bit anxious now knowing February 3 is around the corner.
February 2, 2011 Day before procedure
Days leading up to tomorrow`s procedure seem anxious. I received a call from my research nurse Ann to verify check-in time. Now I sit here a few hours away from turning in for the night. I have come to realize this is not so much of the procedure, but more of appearance. In materials that I have read was the issue of how one looked with a catheter in your chest. Knowing this will be a quality of life change, I am also keeping in the back of my mind this is one hope I have for myself.
February 3, 2011 Day of Procedure/1st Visit
The day has arrived for the placement of the catheter. I arrived at St. Louis University Hospital where the procedure will be performed. I met right away with my research nurse Anne who led me up to the radiology floor. I checked in and was led to a holding area where I was to be prepped for the procedure. Routines questions were asked, vital signs taken, consent forms signed for the procedure, and an IV was started. I met with a doctor who performed the procedure. He explained and showed me how the catheter would be placed. A short while passed before I was taken away to a room for the procedure.
At this time, I was feeling at ease. I have to give credit to the team performing the procedure for easing me through the process. I have to give huge credit to my wife for the support as well as my research nurse Anne throughout this whole journey.
Once I was in the room, an area of my right side of my chest was shaved. They pushed a medicine through the IV to put me in a “light sleep”. The actual procedure took ten minutes for the placement of the catheter. I was taken back to a room to recover for an hour. Once I recovered, I was taken from the hospital to the clinic for my first infusion. My wife was trained for this transfusion procedure at my screening visit to perform this procedure. The infusion was performed which takes 25 minutes. The syringe is attached to the catheter tubing then placed on a pump device that pushes the drug into my body. I also had to take a drug called Ursodiol to help prevent from gall stones. Please remember, this is a random study which means there is no guarantee I am receiving the drug Ceftriaxone or even Ursodiol. Only 2/3 receive this and 1/3 receive placebo substituting the Ceftriaxone or Ursodiol.
A three hour waiting period was needed after the infusion to check for any immediate reaction. Once the waiting period was over, we were able to go home after a long 6 hours. Once I arrived home, I mainly rested. I had some side effects from possibly the anesthesia feeling nausea, headache, and feeling clammy. My oldest daughter was home taking care of my younger sons. I made the decision to show my boys the catheter so they could get an understanding of this process. Their reaction was of curiosity. Some questions were asked and answering them on their level. I ended up sleeping most of my day and evening finally retiring for the night. Now the procedure is complete, only time will tell of my journey.
February 10, 2011 2nd Visit
Today was the first visit since my placement of the catheter at St. Louis University. I met with my coordinator Anne Fanne. The purpose of this visit is to examine the site of the catheter, make sure of no sign of infection, change the dressing, and check vital signs. Upon the examination, all things look good. One question was asked of me as to why a catheter is used in this study versus a port. A caregiver is usually the person administering the Ceftriaxone. In some cases, the caregiver can be much older making the catheter easier to use. A catheter is an attachment process as a port is using a needle to administer. There is a possibility of sticking yourself in use of a port where there are no needles involved with the catheter. Bottom line, the catheter is easier to use for those of age.
Now it has been brought to my attention that I am the only participant at St. Louis University currently on this drug/placebo for this study. Three other people were on the drug/placebo but had to withdrawal due to various reasons. You do remain in the study even though you are not actively on the drug/placebo. I have also learned for those of you on Facebook, there is a Ceftriaxone page. This page was designed for patients currently in this study to go and share their journeys with others.
February 17, 2011 3rd Visit
This was my second visit since my procedure. The purpose of this visit was again to examine the site. Upon the examination, my research nurse (Anne) was very pleased upon visual examination. A pinkish area from cleaning of the site was of concern from the last visit. Explaining to Anne, my skin is extra sensitive which is probably the reason for the reaction of my skin from the items used in cleaning the site. My vitals, blood drawn, and urine were collected, and dressing changed. Complications of the kidneys can set it from the effects of Ceftriaxone is reason for the blood to be drawn. To this point, everything appears to be going good. Next visit on March 3rd will require full strength assessment.
March 3, 2011 4th Week
One month since my procedure, the first strength assessment since the study has started for me. At this time I have not seen any progression. Does this mean I am receiving the drug Ceftriaxone, not necessarily? If you remember, the purpose of this study is to see if this drug is showing possible signs of slowing the progression of the disease. I believe to do a fair analysis for myself I may need to wait until at least my next appointment scheduled for March 31st. The strength assessment is completed by checking upper and lower parts of the body. My muscle groups are measured with a hand held Dynamometer. A Jamar grip dynamometer meter is used to measure my hand strength. The measurements are recorded and used to compare against the baseline measurements recorded back at the pre-screening. As I have discussed with people, I do not have a full understanding of these measurements. I will rely on my judgment of what my body is doing through the muscle movements. An ultra-sound was also done still in search for any possible development of gall stones. A development of gall stones would happen in the early stages of this study. March 31st will be my next appointment for a strength assessment which will include an ultra-sound.
March 9, 2011 Update from March 3rd Visit
I received a call this morning from my research nurse. There is a concern from my results in regards to my ultrasound during my 4th visit back on March 3rd. It has been discovered some “sludge” has developed since the start of this study. “Sludge” is a form of gall stones and is a direct result of the use of Ceftriaxone. With almost certainty we can say the drug Ceftriaxone is being used in my case. There is a possibility that the “sludge” could form into gall stones. Even though I am taking the drug Ursodiol does not guarantee the prevention of gall stones. At this time, I have been instructed to reduce my dosage of Ceftriaxone from twice a day to once a day. I am to continue taking the Ursodiol twice a day. The hopes are to reduce the dosage, no further development of “sludge” or gall stones will appear. Unfortunately, if gall stones were to develop, my participation would end in this study. Feeling of some disappointment of this development, my research nurse reassured me to stay hopeful.
My next appointment (8th week visit) will be on March 31st for an ultra-sound. More than likely my coordinator/nurse will add an additional ultra-sound at the 12th week mark. Normally there would not be another ultra-sound scheduled until the 20th week. This is to monitor and make sure there is no further development of “sludge” or gall stones and hopefully it will disappear.
March 31, 2011 8th Week
My appointment was scheduled for 10:00AM this morning requiring some blood to be drawn and a ultra-sound. Due to some “sludge” build up in my gall bladder that appeared on my last ultra-sound, this ultra-sound is now more important. My dosage of Ceftriaxone was reduced to once a day in hopes of reducing or resolving the “sludge” from my gall bladder. The blood draw is also to keep a watch of my Neutrophil levels in my blood which affects my immune system. This is another direct side effect of the Ceftriaxone drug. By middle of the afternoon, I received a call from my nurse coordinator Anne Fanne. She told me the results of the ultra-sound that there was no significant change with the “sludge” in my gall bladder. Even though it is not the best of news at least there is no increase of the “sludge”. Now I continue the infusion of Ceftriaxone only once a day until the next ultra-sound. Normally there would not be another ultra-sound scheduled until the 20th week but with this development of “sludge”, it is recommended to do one at the 12th week. My next ultra-sound is scheduled for April 27th provided I have no further symptoms occur before that time.
April 27th, 2011 12th Week
My appointment was this morning. My vitals, blood drawn and an ultra-sound was on this morning`s agenda. The main concern of this visit is the development of “sludge” in my gall bladder. The normal routine is to receive a call from my research nurse with the results of the ultra-sound. I received that call the following day with some disappointing developments. It was discovered through the ultra-sound I now have gall stones. The “sludge” that developed was actually hiding the gall stones. It was not until the 12th week visit that the gall stones were discovered. They compared the 4th week with the 12th week ultra-sound results to come to this conclusion of having gall stones since the 4th week. My immediate thought was I am done with this study participation. Way back during the interview process for participation in this study, it was explained to me that with development of gall stones, the participant would be terminated from the study. During the discussion with my research nurse she found out I actually can stay in the study if I would need my gall bladder removed due to gall stones. Steps are taken during this time. The infusions of Ceftriaxone are stopped. Surgery intervention to remove the gall bladder, another ultra-sound is done for reassurance purpose. The study sponsor then makes a decision for the participant to re-enter the study.
The next step for me is to monitor my situation. Make sure I do not become symptomatic meaning no development of pain. A person can have gall stones with no knowledge of it due to a lack of symptoms. My 16th week visit will require a full physical and an ulrta-sound. If my condition stays the same, my dosage of Ursodiol will be increased to three times a day. This is to hopefully decrease the gall stones. This is not a scheduled ultra-sound for the study but an ultra-sound that is needed to monitor the stones. The normal study schedule for ultra-sounds is at the 4th, 8th, 12th and 20th weeks. If “sludge” or gall stones were to develop, it would be during these weeks in the early stages of this study.
May 19th, 2011 16th Week
Now sixteen weeks into the study trial. My visit today requires a full physical and ultra-sound. My physical revealed some positive news. The results of my strength tests revealed little to no progression of the disease. The results that we recorded were compared to numbers from week 4 which was my last strength testing. One could assume the lack of progression would be due to the direct result of the drug Ceftriaxone. An ultra-sound was performed with results revealing no change in my gall stones status. Normally the protocol calls for an increase in this drug to 3x a day to try and break up the stones.
I have overseas travel plans from May 22nd-June 4th. Because of my travels, my research does not want to increase the Ursodiol in fear of any complications may set in. Since I will be overseas, this allows me to go on a drug holiday. This means I will discontinue my infusion of the drug. I do continue my flush of my catheter twice a day and continue my 2 doses of Ursodiol. My next appointment will be at the 20 week mark for another and hopefully final ultra-sound. Once I return from my trip, I was instructed to visit a specialist to further look at my gall stones.
June 9, 2011 Specialist Visit
I returned from my overseas travels with no complications. While I was gone, I received an email from my research nurse to increase my dosage of Ursodiol. I have been instructed to take 3 tablets daily. This of course is to try and dissolve the gall stones that have developed.
With concern of my development of gall stones, protocol calls for me to visit a specialist. This is to get a second opinion on what direction to pursue. Upon my visit with the doctor, various questions were asked about my history which resulted into the development of the gall stones. I was told remaining without symptoms would be safe to proceed. There are many people who live and even do not know they have gall stones. One concern the specialist had was that one of the stones was 2.5 centimeters in size. He felt this size would be difficult for the Ursodiol drug to dissolve. The drug is able to breakdown gall stones 1 centimeter and smaller. The specialist advised if I was not benefitting anything from the study to discontinue it. Even though I do not know 100 percent I am receiving the Ceftriaxone drug, I am certain due to the side effects of the development of gall stones. With the results of my last strength tests revealing no progression of the disease, it only makes sense to continue the study.
June 30th, 2011 20th Week Visit
My visit was routine for the study. My vitals were checked, blood drawn for testing. I also had my final ultrasound for this study. The results of the ultrasound revealed my gall stones and sludge have dissolved and cleared up. I expected possibly for this issue to improve but did not expect the ultrasound to be that good of news. I have to keep in my mind I was not doing my infusion for the last 3 of 4 weeks. I was traveling therefore resulting in a drug holiday as it is referred. One might ask what that has to do with it. If I am to assume I am getting the drug Ceftriaxone, this would explain the ultrasound results. By not doing the infusion, my Ursodoil drug (gall stone preventer) dosage was increased to 3 times a day; this surely would have produced good results. Of course of I do not know for sure I am receiving the drug, I only hope. To not have gall stones at the start of the study, stones developed after 1 month then disappear after an absence of 3 weeks from the diffusion almost seems coincidental. Bottom line, my gall bladder is clean so that takes the worry away.
July 20th, 2011 24th Week Visit
Went to my routine visit, this marks my 6th month in the study trial. Since my last visit I have developed a possible allergic reaction to the drug. I have a mild irritation (Itching) in the facial area. Starting halfway through the diffusion process and ending about 20 minutes after the diffusion process. I made my research nurse aware of the situation. She made note of it in my records. As long as there is no other development stemming from the irritation such as a rash, pain or breathing difficulties, the irritation will be monitored. My body could be reacting due to my drug holidays from a couple of months ago. I basically was off the study drug 3 out of 4 weeks from the middle of May to the middle of June. The body can do mysterious things.
I have learned there was a concern with the sponsors of the study with other study trials coming on board in the research field. With the number of trials increasing, the interest in current studies could drop off. So the sponsors of this study made a decision to drop the number of enrollment required by this study. The original number of participants was 600 and was decreased to 500. Currently, only 48 more participants are needed to reach the new goal. That goal should be reached by no later than the end of 2011. Once the goal is reached, the study will be closed out one year from that point. The sponsors will collect their findings and submit their findings to the FDA hopefully for approval.
August 17, 2011 28th Week
My vitals were taken and recorded, urine specimen collected. The number of volunteers needed for this study is now at 39. I still think it may be the end of the year before the goal of 500 is reached. My next visit, I will go through the strength tests. I am somewhat anxious when I go to this particular visit for it will give me an idea of how my body is reacting to the drug. Again, they will measure my strengths and take the numbers and compare them to the baseline which was recorded back at the beginning. The last strength test showed very little progression.
September 15, 2011 32nd Week
Each week that now passes is becoming a milestone for SLU`s clinic. I am apparently the longest active patient on this drug currently enrolled in the study at this clinic. Attending this visit, the study protocol called for a strength test. The study revealed little progression from the last test back at week sixteen. My left hand was only the noticeable change in showing some weakness. My breathing was fine. My upper body region, arms, shoulders revealed higher numbers (stronger) than the previous visit. Does one scratch his head on that or take it with a grain of salt. Nothing is coming to me as a surprise since I am experiencing the changes within my body. After all, I am the true judge. A number of 31 volunteers are still needed to reach the study goal of 500. I was told 8 patients were in pre-screening so we will see how many passed through to actually participate in the study. The true good news since my last visit was the discovery of the cause of ALS. The article can be read on this site to learn more about it. I believe this is half the battle of learning the cause; the other half is now how to conquer the disease itself.
October 4, 2011 36th Week
This was a routine visit of checking my vitals. As for my progression, it seems frustrating due to the progression is so subtle in change. If I look back to February when I entered into this study, I was using no canes to assist in walking. Fast forward to October, I now use 2 canes. The big question seems to be in my mind, is this Ceftriaxone drug effective? Where would I be my overall condition be without it? Not walking at all? This is one of my frustrations in dealing with ALS; I can only look back over a range of time passed to really gauge my progression. I did find out 11 more volunteers are needed for the study. This number more than likely is reached by next month. The overall goal needed for this study is 500 participants.
November 7, 2011 40th Week
This visit was routine, checking vitals. I did obtain some information from my research nurse in regards to the study. It appears the study will close out in November 2012. The study was in need of 11 participants and they screened 16 patients. They always screen more than needed due to someone maybe ineligible for the study. Now what happens when they study is closed out? Once the study is closed, they will determine whether or not this drug will be effective for treating ALS for all patients. To do the research on the study`s findings can take some time.
In the meantime, all patients enrolled will have the catheters removed and the use of the drug is halted. There is an ongoing debate as to whether or not the patients enrolled should stay on the drug until the FDA comes to a decision of their findings. The problem would be costs involved. Since this study is paid for by a grant, the money is no longer available once the study is closed. If it was allowed, patients staying on the drug more likely would have to be burdened with the costs. I highly doubt the insurance companies would cover any part of this as long as there is no FDA approval. Another argument is leaving the catheter in until a decision is made. It was explained to me that there would be a liability issue. If there was a problem of the catheter line, who is liable? Flushing the lines at the very least would be needed. If the FDA approves the drug to be put on the market, all the patients that were once in the study would have the catheters placed in them at their expense. Some people believe this could be avoided if the catheters could be left in place until a decision is made.
December 4, 2011 44th Week
Today marked my 44th week of my participation in this study. Officially, the study has reached its goal of 500 participants which means this study will close in November 2012. Someone like me can only hope the FDA will not take so much time in their findings. If the protocol remains, all participants will come off the drug during this time. My only reservation is coming off this drug and waiting for a decision from the FDA and then to know my ALS will continue to progress. This study has given me some comfort in knowing I have something to combat this beast. This visit was a routine in checking my vitals, drawing blood and urine. My 48th and 52nd week visits will have my interest since my physical strengths will be tested and measured. The 52nd week also marks my one year mark since I began my participation. My last strength measurement was back at the 32nd week. People often ask me if I notice any changes. I have to respond with an answer of no since my progression is so subtle. That would be a good thing for anyone in my shoes. To measure, I would have to look back over past months and look at different things I did versus what I can or cannot do now. Even though I can walk with a lot of caution, I was walking without assistance of any canes a year ago this time. Now looking back can be depressing, I try and press on and take this on as a life challenge.
January 4th, 2012 48th Week
Today`s visit required a strength assessment. The strength assessment is done every 16 weeks so the last one was done in 32nd week. Only noticeable change was in my left hand. The numbers did not reflect a big change (which is a good sign) so this gives hope. The numbers they use are compared from the previous assessment.
The study has officially reached its goal and the sponsors will be closing out the study in December of this year. The official number of participants is 514. I only want to remain positive and not look too far ahead. Questions will need to be answered after December or into 2013 as to what to do next. I do often wonder had I not participated in this study, what stage of my progression would be at? The most frustrating fact of this disease is progression varies for each individual case. To try and compare your experiences even during a study trial is fruitless due someone else may react/respond different to a drug. For all survivors, the beginning and the ending is the same, the middle (the actual journey) is what is so different. The one comforting thing to know is the year 2011 has brought hope and promise in research. That alone gives survivors like me something to hold onto.
January 27th, 2012 52nd Week
This visit marks my 1 year of my participation in this study trial. The visit was scheduled a week early so I could combine my clinic visit with this study visit. I go to an ALS clinic every 3 months which is provided to me for my care by the ALS Association. An exception had to be requested from the study sponsor according to protocol since this study visit was a week early. This visit required all my vitals, blood drawn, urine sample and physical. This will probably be the last physical for this study due to the study will be closed out in December 2012. The protocol calls for a physical every 52 weeks. My next one would be scheduled in February 2013, well after the close of the study. Reflecting back one year from when I started this study, I was walking without assistance. Now I use 2 canes indoors and the use a wheel chair outdoors for my safety. My left hand is week with loss of finger dexterity. Snapping a finger which we take for granted I can no longer perform.
There are some positive things I feel by looking even further back to my onset which is in early 2008. I am still able to walk even though I use canes for assistance. More importantly, my respiratory numbers are normal. Now the question could be as I wonder if I did not participate in this study, would my condition have worsened. How much? I have to believe my participation befitted me to this point.
February 24th, 2012 56th Week
This month, this visit marks my one year in the study. Approaching my 3rd year since my diagnosis, I am feeling fortunate to have the support through this journey from the health care community. It has been an adjustment in my life as how I do things. As they say, “To get ahead, you have to sacrifice”. In my case, it is staying alive.
March23rd, 2012 60th Week
This visit was routine. Sometimes I wonder why all the fuss in monitoring vitals. But I have to remind myself the complications of gall stones I developed early on this study. If not for the monitoring, I could be in a more worse situation.
April 3, 2012 64th Week
My 60th week in this study, I guess it could be considered of milestone for myself. I have not recorded anything the last 2 months due to not much to log into this journal. Maybe a good thing since there is no drastic changes. This visit is no different, just getting my vitals checked. My next visit, my strength will be checked. I will be curious although the numbers are subjective so you cannot take it to heart. I technically do not need numbers to know what is going on with my body.
April 27, 2012 68th Week
I always get anxious for the particular visit. Every 16 weeks, my strength is measured. Although it is subjective, it stills gives us an idea on the progression of the disease. Again, I am the true judge since I am experiencing the weaknesses. I could say one test; my hand strength is probably the most accurate of any tests. Using a device, it measures pressure of pounds when I squeeze the device with either hand. Now I knew coming to this visit, my left hand became weaker since my last test 16 weeks ago. My left hand measured 10 pounds of pressure compared to 18 from my last visit. And my right hand measured 25 pounds. What is normal? At the beginning of my diagnosis, both hands measured at 110 pounds of pressure. I would have to say my left hand revealed the most progression. Taking all the information and digesting it, you wonder if the progression is speeding up. You hear of cases of increasing of progression and then it levels off. You cannot compare your case to others for everyone is different. By doing so, you will cause you self needless worry.
May 23rd, 2012 72nd Week
This visit was very routine, vitals, blood drawn, ect… Looking down the road I realize this study will finish and close out in December. That will be here before we know it. I often question myself if I was not in this study trial would my progression be further along? This is all based on if I am actually receiving the drug in which I believe I am. The answer to my question will never be answered although I am grateful for the opportunity to participate.
June 24th, 2012 76th Week
This visit was routine. It seems like now after each visit I reflect back to the start of the study and realizing my abilities as to what I could or could not do. Realizing I could walk with no assistance to now I am using a power chair. My walking abilities only assisted by a walker at a very slow pace. I question the study and its purpose sometimes but I will be fearful when December arrives and the catheter is removed. Fearful the progression of ALS will increase in my body. This is why I adopted the “one day at a time” thinking so I do not get too far ahead of myself.
July 27th, 2012 80th Week
Went into this visit thinking it would be very routine, checking vitals, blood drawn, ect.. And it was until about a week later when I was told the study was ending and the catheter would be removed immediately. The removal was not scheduled until December so this was a big surprise. It was explained to me the data being reported within the study revealed the drug was not effective for use. This is one of the negatives of research when you put hope into this especially when it reaches 3rd phase. It is not a guarantee at any stage but the further along the study advances, the more hopeful for the outcome of the study trial. I will admit my disappointment of the news but do understand.
August 15th, 2012 The End
This visit marks the final visit and removal of the catheter. A final physical and check of vitals is required before the removal procedure. A check of my hand strength did reveal my left hand was significantly weaker than last physical. An instrument used to measure pounds of pressure when you squeeze the instrument revealed 10 pounds of pressure last visit. During this visit, only 2 pounds of pressure when I squeezed the device with my left hand. Although I feel the weakness without needing to measure, I was surprised at the difference between the present and last visit. Once the physical was completed, we moved to the hospital for the removal procedure. Now I can tell you I was a little nervous not knowing what to expect. The procedure from start to finish was about 15 minutes. Once the area was numb, I did not feel anything. The catheter was in place for 80 weeks so it took some effort to remove it. I was told if my body accepted the catheter, it makes the job a little tougher more removal due to scar tissue that forms around the catheter. This would be a good thing for me and tougher for the doctor removing the catheter. A small bandage was placed over the area and now I only experience a little soreness which I expected. Some people may think this whole experience was a waste of time and money. You have to remember even though this study trial was not a success, data recovered from all that participated aided in the learning of this drug and ALS. I am happy I was able to experience and participate in this study. One of those lessons in life, everything doesn`t always go your way.