Clinical Trials. YES or NO?

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If I was asked to take part in a clinical trial, I’m not sure what I’d say…

First there’s the fear factor. Would I be a guinea pig for something dangerous? Would they take away my meds? Would it hurt me? Would it change something in me?

I asked those very questions to Patient Advocate David Albaugh at Team Epilepsy. http://www.teamepilepsy.org/

He patiently explained that before any clinical trials can begin, the med goes through rigorous testing and must be accepted as viable by the FDA. I’d be able to keep taking my regular AEDs (Whew!) and I’d be monitored very carefully by medical specialists, every step of the way.

That made me feel more secure. Because with every visit, both my health and seizure status would be checked and closely followed. So, if there were any negative effects, the specialists would know immediately. And if there was any danger, my testing would be stopped, right then and there.

Then I got curious. What exactly happens in a Clinical Trial?

David Albaugh explained that it’s really quite simple. Some people are given the actual pill. Others are given a placebo (with an inactive substance in it). Neither the patients, nor the medical team know who has what. (Blind study) Which makes it kind of mysterious and exciting. (It’s like trying to cheat on the written part of your driver’s test. You can’t, because the person beside you has a different test! I learned that the hard way!)

Then I got hopeful. I could learn more about my seizures. I could possibility control them. All it took was trying this new adjunct drug along with my regular meds.

So, I wondered: Could this be the answer? Could this finally be my “magical med” mix?

I have to tell you, I kissed a lot of frogs before I found my answer. From Dilantin (which made me a zombie) to Pheno (which made me a double zombie) and dozens of others over the years.

And like me, you know that finding the right combo of AEDs is a crap shoot. (That’s why they call them “Clinical Trials!”) The prospective med has to be thoroughly tried and tested before it can become available.

But I couldn’t stop thinking: What if this really did work? Then I let my imagination go a little wild and thought, what if this could lead to more freedom? (Bye-bye helmets, bye-bye cane! Yeeee Haaaa!)

More importantly, I wondered, What if this new discovery could help control not only my seizures but also other people like us?

We all know that nobody wants epilepsy to rule their life. And nobody should have to. That’s why this Team Epilepsy project gives me such hope.

There’s this wonderful saying: “When the world says Give up, Hope whispers: Try it one more time.” Sounds like good advice to me…

NOTE: Text taken from an interview with David Albaugh, Director of Patient Advocacy, Team Epilepsy (http://www.teamepilepsy.org/)
 

Rae1889

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I recently was chatting with the makers of EpiLert (the company is called BioLert) and they have me on their list when they can start doing in home trials of their watch like device that detects abnormal movement (seizure) and texts/calls the emergency number listed to leave a prerecorded message saying that the person is having a seizure. Or ther is an alarm receiver too so you can take a bath and then whoever is home will hear the alarm go off.
 

Cint

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Then I got curious. What exactly happens in a Clinical Trial?

David Albaugh explained that it’s really quite simple. Some people are given the actual pill. Others are given a placebo (with an inactive substance in it). Neither the patients, nor the medical team know who has what. (Blind study) Which makes it kind of mysterious and exciting. (It’s like trying to cheat on the written part of your driver’s test. You can’t, because the person beside you has a different test! I learned that the hard way!)

Then I got hopeful. I could learn more about my seizures. I could possibility control them. All it took was trying this new adjunct drug along with my regular meds.

So, I wondered: Could this be the answer? Could this finally be my “magical med” mix?

I have to tell you, I kissed a lot of frogs before I found my answer. From Dilantin (which made me a zombie) to Pheno (which made me a double zombie) and dozens of others over the years.

And like me, you know that finding the right combo of AEDs is a crap shoot. (That’s why they call them “Clinical Trials!”) The prospective med has to be thoroughly tried and tested before it can become available.

But I couldn’t stop thinking: What if this really did work? Then I let my imagination go a little wild and thought, what if this could lead to more freedom? (Bye-bye helmets, bye-bye cane! Yeeee Haaaa!)

More importantly, I wondered, What if this new discovery could help control not only my seizures but also other people like us?

We all know that nobody wants epilepsy to rule their life. And nobody should have to. That’s why this Team Epilepsy project gives me such hope.
Back in the 90's I was on a drug study for Sabril. I don't know if I was taking the "real" drug or the placebo, but whatever, it didn't do the "trick" for me. Plus, they found Sabril caused peripheral blindness for 40% of patients, and it was rejected by the FDA in 1998. Another biotech company, Ovation Pharmaceuticals, picked it up and it took 6 years for that company to get approval for the drug here in the U.S. For more on the subject, go to: http://www.wellsphere.com/epilepsy-seizures-article/sabril-vigabatrin/821401

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
 

epileric

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I asked those very questions to Patient Advocate David Albaugh at Team Epilepsy. http://www.teamepilepsy.org/
I would be very careful of David Albaugh. Be aware that he also works for MediciGlobal whose job it is to recruit people for clinical trials.

MediciGlobal® is a specialty patient recruitment-retention firm serving the clinical trials industry. Liz Moench’s founding vision in 1991 was to create a company that addressed the primary cause of clinical trial delays: ineffective patient recruitment.
This does not mean that what he's saying is not true but be aware that he does have his own motives to be as encouraging he does.
 
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Cordero

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I'm in a clinical trial right now for the RNS system. I really didn't have much of a choice on whether to participate or not. It was either have uncontrolled seizures, up the dosage I'm on, give the study a try, or try a new medication. I decided to go with the study. Everything's going great so far but I'm aware that I need the battery replaced about every three years until they come up with a rechargable battery. All I can say is trust God and take it one day at a time.
 

Endless

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I can't speak for others, only myself. IMHO.....

I wouldn't participate in a TREATMENT clinical trail unless I was desperate. Every other avenue of treatment had been tried, and it was worth serious damage to my health and/or death to try the new drug or device.

The consequences of participating in a clinical trial can be quite high. During a phase III trial, when patients would be most likely to participate, the side effects on humans are not known. The research on the drug before that point would be on animals, and be so limited on people (under 300 or so people) that a serious or fatal side effect could be unknown.

In fact, side effects often aren't known even after the trial, since they are usually short term studies and don't measure the long-term effects of the new drug or device. A Phase 4 trial collects data "post marketing," which means after it goes to market. But all reported side effects don't make it to the FDA. A doctor or patient has to report it to the FDA and they hardly ever do.

A person could be exposing themselves to potential harm that is irreversible and unpredictable. What's more, drug companies' main concern is profit, not the best interests of the people in the clinical trial for a drug they've invested $x millions of dollars in already. A drug not making it through clinical trials could literally bankrupt a company, especially a smaller biotech company. That means a serious potential conflict of interest. The docs are supposed to help prevent this, but some docs get the majority of their compensation from clinical trials. So there's a conflict of interest, too.

When they talk about a "double blind study," that is not mysterious nor exciting. It's a way of packaging the message that you may not get treated. At all. No medication. Nada. For people with a serious illness, that can be dangerous and could cost a person their life. That's why for diseases like cancer, they don't use control groups who are unmedicated/untreated because it would hasten their deaths. I guess the same consideration is not given to epilepsy, even though SUDEP happens in 1 in every 200 people with epilepsy, and most of these deaths occur when the patient is under-medicated.

Some people are driven to clinical trials because they are literally out of options. They have tried every treatment currently available, and they have been told they will die or suffer long term damage unless something else is found. Some people can't afford treatment, they just can't keep living with their disease, so they enroll in a clinical trial out of desperation. If it wasn't for the clinical trial, they'd get no treatment at all. For those people a clinical trial can be a lifesaver.

I'm not saying all research is bad. It's how we get the drugs that help us. I'm just saying I personally wouldn't enroll in a study unless I had no other choice.

Here is an outline of what a clinical trial is:
http://clinicaltrials.gov/ct2/info/understand

http://en.wikipedia.org/wiki/Clinical_trial
 
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carolyn

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I think I also wouldn't participate in a drug trial unless I were absolutely desperate. However, if the trial used some behavioral intervention (e.g. neurofeedback) that couldn't really cause any damage, I would probably go for it.
 

Cint

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I think that if you're already "allowed" to stay on your meds, they would act as a "safety net."
When I was participating in the drug study, I was also on another medication, so I didn't go completely off medication. But I still had multiple seizures during that time.

From Endless:
I wouldn't participate in a TREATMENT clinical trail unless I was desperate. Every other avenue of treatment had been tried,
This is the only reason I agreed to partake in a clinical trial. By this time I had the unsuccessful LTL, tried numerous drugs and was still having CP's and TC's. But after the disastrous experience of the clinical trial, I won't do it again.

From Endless:
In fact, side effects often aren't known even after the trial, since they are usually short term studies and don't measure the long-term effects of the new drug or device. A Phase 4 trial collects data "post marketing," which means after it goes to market. But all reported side effects don't make it to the FDA. A doctor or patient has to report it to the FDA and they hardly ever do.

A person could be exposing themselves to potential harm that is irreversible and unpredictable. What's more, drug companies' main concern is profit, not the best interests of the people in the clinical trial for a drug they've invested $x millions of dollars in already. *A drug not making it through clinical trials could literally bankrupt a company, especially a smaller biotech company. That means a serious potential conflict of interest. The docs are supposed to help prevent this, but some docs get the majority of their compensation from clinical trials. So there's a conflict of interest, too.

When they talk about a "double blind study," that is not mysterious nor exciting. It's a way of packaging the message that you may not get treated. At all. No medication. Nada. For people with a serious illness, that can be dangerous and could cost a person their life
.

*(This is what happened to the pharmaceutical involved with Sabril).

Plus after brain surgery, I went thru many drugs for depression and finally my neuro-psychiatrist put me on a drug used for bi-polar, Zyprexa, and they were just finding out in the U.S. that is can cause diabetes in some. Well, I happened to be one of the ones who is damaged for life because of that freakin' drug and the FDA wasn't telling the truth. Hmm.... the drug was taken off the market in Japan because people were dying. So to the pharmaceutical companies, we are just another #.

Be very careful and ask, ask, ask and keep asking questions!!!!
 

Cordero

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One thing I forgot to mention about the clinical trial was that all my medical bills involving the treatment of this study are paid for. I also get paid $25.00 for each appoinment.

I still have to take my seizure meds, though. My doses can't change until the study is over or if there is some medical emergency. When I enrolled in the study I thought I could stop taking my medications but my doctor said no. He said to look at this as though we are trying to get better control of the seizures. He also said that when the study is over and if I show seizure control for a period of time he could very slowly reduce them. I'm not at that point yet but one less seizure to worry about is good enough for me.

For some it works out and for some it doesn't. You just have to weigh your options
 
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I am in the RNS trials myself, it has been a rocky ride, but the epilepsy center and neuropace have been great. I lost my insurance when the company I worked for found a loophole around my ADA accomodation and fired me, when that happened neuropace started covering the charges. Since I live so far away from the center too, they are willing to cover my hotel costs when I have multiple appointments, so I can't complain.

Clinical trials may sound like something scary, but they are closely monitored and under the eye of the FDA also. For many of us, it is one of the last options we have as meds may not help. I have had great luck with mine I believe. Granted the first 6 months were rough with a double blind study and not knowing if it was on or off, but it was worth it I think.

I would recommend this to anyone if it gains FDA approval as it is also helpful in them being able to track your seizures better.

Another thing I added to my regimen of meds and the RNS is that I recently started a modified Atkins diet and monitor my ketosis level. since I went into a ketogenic state I have had even more improvements, along with more energy, sleep better, lost my craving for sugar and lost 5 lbs in one week. I'm gonna keep this monitored and let my doctors know about it. They knew I was thinking about it and so I decided to give it a try after all the info I found on it.
 
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