Thoughts on Clincal Trials

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hopeandlove

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Just curious if anyone has any experiences with clinical trials. Very mixed emotions about them. More interested in the new treatment/drug trials instead of the survey type trials.
 

BethU

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Hi ... I've been on a drug trial at UCLA since about September or October. It was a double-blind study of an emotional lability med. I finished the trial last week and immediately started an open label study of the same drug at the same visit.

I enjoyed the experience: for one thing, you get a LOT of attention and face time with the neuro. Since I'm fairly new to ALS (six months since diagnosed, about half of it spent in denial), it gave me a place to get feedback, ask questions, etc. Also: Free meds for a symptom that I really need help with. :) Also: You get paid a little (I think it's $50 per appointment.) I like the idea of doctors paying ME something for a change!

Disadvantages: Driving 17 miles in LA rush hour traffic = 1 1/2 hour drive there, 1/2 hour home. Couldn't get later appointments. Also, having to deal with blister paks of meds and keep a diary, paperwork, etc. Frequent appointments.

Best part: I found a drug that helps with the emotional lab (the "real" drug now is having exactly the same effect as the unnamed one, so I'm pretty sure I was getting the real deal and not a placebo.)

I thought it was a win-win situation.
 

elemkay80

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I don't have experience with any related to ALS, but I did participate in one about 6 years ago for that birth control med, Seasonale - the one that gave you a period only 4 times a year. The trial was the last one being done before it would get FDA approval and the trial lasted for 1 year. It was a great experience for the most part. Like Beth said, you get lots of freebies and even get paid in many instances. For me, I got free birth control for 1 year (it was guaranteed to work as well as the one I had been on), $750 at the completion, and a free PDA. I also got 2 free "annual" exams. All of this for a struggling nursing student was excellent in my book! Downsides - it was being done out of a university in Norfolk, which was 2 hours from where I lived. Also, I had to document in a special program on the PDA various symptoms and feelings and upload it every day. The worst was having to have 2 endometrial biopsies, as the study was being done to determine if there were any significant changes. Overall though, I think it was worth it. If I had the opportunity to do another at some point, I probably would.

~Michelle
 

KellyandKay

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My wife was in a clinical trial for minocycline, a commonly-used antibiotic. Preliminary trials had shown promise and some PALS were already using it. Kay had severe side-effects and had to stop using the drug (although she stayed in the study to contribute to the research data base.) The study found that minocycline did not help, and in some cases appeared to do harm. The researchers advised PALS to discontinue use of the drug. Kay did not regret participating in the trial, because even negative results help researchers, and in a small way, she was able to help others suffering with ALS. One advantage of participating was that she got excellent advice and help with prescriptions from the trial doctors and technicians. This continued even after she was no longer able to make the trip to the clinic.
 

brooksea

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My husband has been in the AVANIR trial for emotional lability. At first we thought he was receiving the placebo, but eventually realized things were getting better.

We now think he was on the lower dose for the trial and now he is receiving the full dose for the open trial.

I can report that this drug has not only helped emotional lability, but has helped with the choking/gagging with saliva. He's not had a serious episode for about 5 or 6 weeks or more! The saliva has diminished and I believe it has to do with the DM in the drug.

My husband also participated in a "super" MRI trial. He went twice and we both agreed that he would not do it again! It literally sapped the energy out of him and left him unable to lift his arms after.

Choose trials wisely. You can always opt out!

My husband wants to help future generations with ALS, but he also wants to not deteriorate because of a trial!
 

CindyM

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Glad to hear this, CJ. It sounds hopeful, but more importantly I am glad to hear that your DH is getting some relief!
 

BethU

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CJ ... interesting to hear about your husband's experience. I'm in the same trial, and in the double-blind test I got amazing results from the first pill onward. Like your husband, the relief went way beyond just the emotional lability. Now, for the last couple of weeks I have been in the open label trial, and most of the benefits have gone away. I've had three emotional meltdowns, etc. The only difference is that the emotional meltdowns were not as violent as before I started the trials.

At the clinic this morning, the neuro investigated a little, and it turns out I had been on a stronger dose in the double-blind part. Now for the open label, I'm on a lower dosage. I'm going to have to stick with the trial for another month (it goes on for two more months), but hope I can switch back to the higher dose asap.

Thanks for sharing that info ...
 

brooksea

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Hey Beth,

Didn't know they would tell you what dose you were on for the blind trial, but my husband swears whatever dose he was taking was something other than "sugar."

He is really doing a lot better with the emotional lability and even his speech seems to be better in the AM. I'm thinking that is because the saliva is reduced (DM in the medicine) and therefore his tongue doesn't have to work harder to move it out of the way to talk.
 

BethU

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I also noticed an improvement in my speech, but I felt it was because I was able to put more force into speaking. The improvement in energy was great. Glad your hubby has good results too.
 

hydrasquad4life

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Beth and CJ

I am a stock investor of Avanir and have been reading your stories

Have you talked to other patients? I'd like to know more about the success stories with Zenvia. I'm very glad to know Zenvia works for you guys (as a person not stock investor)

Andrew
 

BethU

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I guess I've been posting my not-so-successful stories on another thread. I've had awful experiences since I went from the double blind to open label test phase. In fact, the worst outbursts of lability I've yet experienced. Fortunately (or not?) one of them happened at a clinical trial appointment, when I lunged at the director of the test and she had to get help. I'm extremely concerned about the rage and anger.

That was the first bottle of meds on the open label. The second bottle I received, worked better, although I again had a really bad uncontrollable outburst for over 40 minutes.

Nobody knows why this is happening, altho the neuro did say that it happened with a man in the trial earlier ... after successful control with the double blind study (placebo effect? then why wouldn't it continue?), his emotional lability returned when he went on the open label, i.e., drugstore-available meds.

I am wondering if it is a question of older meds (near expiration date) being given out in open label trial; or a question of quality control at the manufacturer; or (most likely) a lower dosage in the open label. I will have my last visit next week and see what transpires.
 

Marjorie R. Wilcox

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Just curious (and interested) Beth. How do you know that your outburst wasn't just a natural reaction to your frustrations.... or the result of a few months of tougher times while thinking of and getting the peg tube etc.? This is an honest question, and I'm not picking on you. I know there are times when Rick and I could say a few choice words, but don't.
 

BethU

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Hi, Marjorie ... if Rick ever has an emotional lability meltdown, you'll know.

First: both crying and raging are like nothing I have ever experienced before. This last one started with me screaming ... like in Hitchcock ... real screams (never done that before). In crying meltdowns (like at Kinko's when the clerk was so nice), it was shrieks at the top of my lungs. The whole mall went on lock down. Shrieking and sobbing and skrieking and sobbing. I was trying to get out of there as fast as possible before I got arrested, but you have NO CONTROL over this. Your body takes over. So I went shrieking through the store and the mall and the parking lot, with people slamming on their brakes, whirling around and staring at me. This was because a salesclerk was extra pleasant! The outbursts last about 40 to 45 minutes and I'm exhausted by it.

Your brain is not affected ... you're thinking furiously how to make it stop, and trying to get yourself to breathe. It is very much like the seizures I have had in the middle of the night, where my arms are flailing back and forth and my legs are jerking straight out ... and I can't make them stop! It is scary as hell to be "imprisoned" in a body out of control ... whether shrieks or flailing .... and not be able to stop it from happening.

When I got home from the Kinko's episode, still shrieking ... I'm talking top of my lungs here, Marjorie ... and my husband was wildly alarmed, I was able to type on my Light/Writer "Ignore me this is just the ALS again." But it really shakes up my husband (and everybody else I see). And me.

Emotional lability is not "normal emotion" expressed at an inappropriate time ... or an appropriate time. It is something I have never experienced in my life ... it is like being a wild animal, or insane? I don't know what to compare it to. My body has never made those noises before. And it cannot be controlled. You cannot stop screaming/shrieking and sobbing.

When it happened at the UCLA clinic, and I lunged at the doctor and she ran to get help, she clearly had the impression that I might do anything. And I feel the same way. I know once one of these starts it's not going to be over till its over and I have no control over it.

It's nothing like a "normal reaction" to frustrations, or having a "few choice words" with your spouse. Nothing. It's a different universe. I guess unless you've experienced it or seen it in action, you can't imagine it.

We had a thread going on Patients Like Me on this topic, and there were several others who have had these same intense episodes, and two of us agreed that it is something primordial ... it is coming from way, way down in the lizard brain somewhere.

This is why I feel I may have FTD also, or some sort of dementia trying to break through.

On the other hand, I'm in LA and the sun is shining and the daffodills will be up soon and I just had my carpets shampood and everything smells nice (even me) and ... and ....

Speechless in L.A. :lol:
 
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