I am humbled by people who participate in clinical trials. There are many unknowns about the therapies being tested, such as potentials risks or side effects, whether you are getting treatment or placebo. In addition, there are often extra responsibilities for clinical trial participants, such as MRIs and other tests, frequent appointments with study staff and other tasks like maintaining symptom logs. Have you been in a clinical trial? What was your experience? Which questions do you wish you had asked before the trial started? What tips or advice would you give other people who are considering a clinical trial? Share Your Story
- I was diagnosed 2010. This year I have driven 100 miles round trip to participate in Clinical Trials. One is a LP every six months to monitor my fluid compared to others. The other one I dont even remember (LOL). But the one I was most exited about was one for PPMS. I had tried to get in last year but my levels of a protein i had were 2 low. They called me back again this year and told me they changed the criteria. After 2 more days of driving and getting pricked through my non-existent veins I was told my levels are even lower. When I see the dr I will ask the significance. My point is anything that will help find a cure or cause is relevant enough to me to make the trip especially if its regarding PPMS. I think the study was the Oratorio in case anyone is interested. I was very disappointed that I couldnt be in that trial as there are just a handful of studies related to PPMS. Good luck.
- I participated in a drug trial for 6 months taking copaxone and teriflunomide. They monitored me very closely, which required several brain MRIs, scans of my liver, pancreas, and heart. I was either on a placebo, 7mg, or 14mg. I felt great, but my hair was falling out. I know I was either on the 7mg or 14mg. I liked the additional face time with my doctor while doing the trail. The biggest disappointment is not knowing the results of the trial. I've asked my doctor every time I go in for my appointments, and she doesn't know either. To go through all the riga-ma-ro of this, and then not have anybody follow-up on it is very frustrating!
- —Guest Mary C
Decided for DECIDE
- I'm on Biogen's DECIDE comparing Avonoex with Daclizumab High Yield Process (a humanised monoclonal antibody). It is double-blind and randomized. I was just diagnosed in January, so the study is the first MS drug of any kind I've been on.
My decision was threefold: 1. gambling that I might take something even more effective 2. knowing that my interaction with the doctors and nurses is much more frequent. This early in the game, I like that I am closely monitored and I appreciate the hand-hold and monthly discussions as I get into the MS groove. I am part of four studies altogether (the others being academic and just needing various samples)
3 The one that sealed it for me was a real sense of 'pay it forward'. I'm freshly (and unexpectely. No limboland.) diagnosed. The road I face is unpredictable, sure, but statistically it's looking far better for me than for those before me. And that's thanks to past research, past volunteers. And the notion of running a 5K to help does NOT appeal
On going clinical trial
- I am currently in a clinical trial with oral Cladribine it has been 1 year already. Am scheduled for a follow up MRI next month and only then will I know if I have been on the real or placebo drug. The side effects of the drug is, it effects the white blood cells hence it has been fluctuating between grade 2 & 3, and 3 being the lowest(bad) meaning a high chance of catching an infection or being more prone to catching something. So far all has been going fine. If after the next MRI and they see more lesions they might switch me to InterferonB.....I hope not cause I hate needles.
- —Guest Susan Fernando
- I have been going to NIH since 1996 when I was first diagnosed and have participated in a several trials. The latest for an infused drug called Zenopax used for kidney transplants. It was a once a month infusion with absolutely no side effects--unlike the Betaseron that I was on before that. The drug company found a cheaper, better drug for kidney transplants and stopped making Zenopax. The neuroimmunology team at NIH got such great results, they submitted a proposal to study a subcutaneous form of Zenopax (by a different drug company). Again, I've had great clinical results with no side effects. In fact, I'm doing better with this version than I was with the infusion. I had no heat related symptoms last summer (and I work in DC, so it gets hot) and feel stronger. My experience with clinical trials has been great. The doctors and staff are specialists in MS (unlike my outside neurologist) and I get better care & more attention from them.
- I am participating in a drug study that compares Avonex and Daclizumab. Beside the typical effects such as aches and pains, I haven't had any problems. I was told yesterday that a patient in the same study passed away this weekend from liver failure so I'm a little concerned now. I'm glad the drug company has chosen to administer blood draws at each visit to help combat the liver issue. If they find out for sure that she passed away due to one of the drugs, I will be more concerned but I understand that it is a trial and there are always risks. I'm keeping my fingers crossed that the medicine helps and has no adverse effects.
- —Guest Amy
Info from those DX with MS
- I have often thought that it would be a great idea for someone studying the MS disease to collect information concerning family ancestry, blood work from MS individuals, disability levels, MRI data, long term symtomology - ANYTHING we already have to help in some way. No one has ever asked me for this information which I find odd...
- —Guest Astronomychick
- I participated in the BG00012 MS clinical trial for 2 years at the suggestion of my diagnosing neurologist. I now use a walker or wheelchair and have new lesions but was told they were not relapses but disease progression...I feel that I have had 2 distinct relapses and am now a critic on the validity of research data.
- —Guest Tricia
Stem Cell procedure
- I underwent a stem cell "transplant" at Northwestern University Chicago in 2004 and have experianced nothing but good results since. Not only have I not had a relapse since but I reversed much of my disability. In the year prior to the procedure, I must have had double digit attacks but it was hard to tell because I didn't have any significant recovery. I had many of the potential symptoms associated with the condition including severe visual problems.
The procedure involves removing some stem cells from my blood stream followed by high dose chemotherapy to virtually eradicate my immune system(the culprit of MS) followed by reinsertion of stem cells via injection. That along with growth factors helped create a new immune system. I guess this can be compared to rebooting a computer after a virus.
And I am not proclaiming this is a cure all as it is very hard to get accepted for the procedure because of potential hazards. This is just my experience.
Importance of studies
- This is a subject I feel very strongly about. I have participated on one clinical trial to date (ASSERT), after my diagnosing neurologist put the idea into my head. The study originally was slated for 36 months, but due to problems at other clinical sites, the study was discontinued by the drug maker just after my two year mark. During the two years, I was followed very closely by the study coordinator and neurologists, which was ideal, as I had been diagnosed with RRMS less than six months prior to the start of study and had many questions/concerns about the disease which I was able to convey to my study team in a timely manner. For me personally, that was very important as a paitent. Currently, I am awating for the final go-ahead from the study team about the next study I will be starting by the end of this year. That being said, my reasons for being involved in the studies are quite simple-- someone has to do it. I feel I owe it to those dealing w/this in the future.
- I have been offered to sign up for a clinical trial on a new drug wich I can't say what is is. I dont know if I should go ahead with it since it can cause pancreatis. There will be three groups and I wont be told which one im in if Im accepted.
- —Guest yetza
- I, myself participated in the oral Cladribine trial. I have yet to find out if I was actually getting the drug and if so what dose. It was a triple blind study meaning that some got no drug, some got low dose drug, and some got high dose drug.
- —Guest Penny
Avonex & Copaxone CombiRx Trial
- I have been on this study for almost 3 years and have just been offered to stay on for another 3 years. I started this study right when I was diagnoised with MS. I have to say that I did not do so well when I first started this study but now I am getting used to the 8 shots a week and the side effects from the Avonex. The Copaxone is not too bad. I do have the real drugs on both of these from all of the side effects that come with both of these drugs. I do like not having to pay for the meds. I have to keep a log for the side effects and they shots and go to the Dr. every 3 months & MRI once a year. Do all kinds of tests as the Dr. enery time I go. As far as my MS is coming along, I have not had any episodes and I count that as a blessing. I will continue this study and the 8 shots a week, this is totally worth not having an episode. I do hope that they can come to a conclusion on this study and hopefully it is best to take 2 drugs to help keep this nasty disease under control.
- —Guest Patty
So far, so good
- I'm also participating in the study that compares Avonex & Copaxone together or each separately. What made my decision to go with this study is that no matter which group I was in, I would be getting medication. No placebo. Given the reactions I've had (mild), I believe I am taking both drugs. I have an appt every 3 months, have MRIs periodically and keep a daily log of injections, side effects & sites. I have had no relapses in the 4 yrs I've been on the study. Mild fatigue can still be an issue. I don't like not being able to see or know what my MRIs looked like so last year I went outside the study & had an MRI. It showed lesions but I was not experiencing any new symptoms. So maybe the meds are working?!?! I started the study shortly after diagnosis so don't have a lot of experience being off meds. I strongly dislike injections, especially the Avonex. Found a neighbor to give it in my hip. Much better than leg. I believe I'll stick with the study as long as they allow it. Good luck
- —Guest smileawhile
- I was on a trial drug Lamotrogine, not knowing whether it was a placibo or live drug. I did not seem to get worse only stayed the same. I was expecting miracle's I had two doctors who looked after me in everyday whilst having MRI'S blood tests and neurogical tests and even had their mobile no's to phone anytime I was worried. That trial lasted for 2 yrs.
After I came off the drug I was going down hill and phoned them. I was told that I had been on the live drug and could go back on it via my GP, which I have.
- —Guest Barbie