Trial for new epilepsy med

Posted by cathy5161 @cathy5161, May 18 2:17pm

Shortly starting an open label clinical trial to evaluate a new epilepsy drug called vormatrigine, developed by Praxis Precison Meds. It's 14 weeks long, divided into extensive screening, and a number of visits with a great deal of assessments and procedures. Belive this is first phase, which I'm sure with no placebo, looking for side effects and adverse reactions to study drug. 50 or so participants, across the globe, who have focal onset or tonic-clonic seizures, all getting same dosage, are the first guinea pigs.
1. Anyone heard of this trial or study drug?
2. Anyone actually doing it?
3. Any other thoughts or comments?

Interested in more discussions like this? Go to the Epilepsy & Seizures Support Group.

cathy5161 | @cathy5161 | May 22 5:47pm

In reply to @santosha "Hi @cathy5161 Today, I came across this article: Common genetic variants linked to drug-resistant epilepsy. @closetmonster93,..." + (show)

Thank you Chris. I will ask my neurologist her take on this.
Appreciate you passing it on.

cathy5161 | @cathy5161 | May 22 6:39pm

In reply to @jamessr "Does anyone have a link on how to contact Praxis for participation eligibility? James" + (show)

Praxis uses contract nurses to do initial pre-screening. The main number I have for that is 866-812-2202. The trial I am in is called Radiance (PRAX-628-212.) It might be full but worth a call.

There are much larger studies to follow - these of the double blind placebo type i think these are labeled "Power".

Chris Gautier, Volunteer Mentor | @santosha | May 22 8:19pm

In reply to @cathy5161 "Thank you Chris. I will ask my neurologist her take on this. Appreciate you passing it..." + (show)

My pleasure @cathy5161 !
I would appreciate if you can share your neurologist's view on that. I will be having an appointment with my immunologist and neurologist in June and will also ask them about it, sharing with you.
Chris (@santosha)

Chris Gautier, Volunteer Mentor | @santosha | Jul 26 9:22am

In reply to @santosha "My pleasure @cathy5161 ! I would appreciate if you can share your neurologist's view on that...." + (show)

Hi @cathy5161
I had appointments with my immunologist in June and my neurologist this month. I have to confess, I completely forgot to ask them about those common genetic variants linked to drug-resistant epilepsy that I shared with you. Sorry about that!
And you, how have you been doing? I'd love to hear any updates on the Praxis clinical trial if you're able to share!
Chris

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cathy5161 | @cathy5161 | Jul 27 2:41pm

Status update: started new trial drug on 6/17. Stuck it out (bad side effects) until I had 3 seizures in July with long, disturbing post-ictal periods after the 1st and 3rd seizure. After that, side effects worsened and i aborted the trial early this week....3 weeks before the last assessment. Couldn't take it anymore, and if I managed to reach the end, looking at a 4 month follow on trial. I understand some participants felt it helped their seizures, and others stopped for various reasons. Who knows?

Chris Gautier, Volunteer Mentor | @santosha | Jul 28 12:47pm

In reply to @cathy5161 "Status update: started new trial drug on 6/17. Stuck it out (bad side effects) until I..." + (show)

Hi @cathy5161
Thanks for those updates.
I'm sorry to get this news from your trial! You gave it your best shot, sticking it out for over a month despite the bad side effects, the seizures you had, and the disturbing post-ictal symptoms. That takes incredible strength and determination! But your safety and well-being have to come first, and it sounds like your body was telling you "enough."
I hope you're starting to feel some relief now that you've stopped the trial, though I know it might still be too early to tell. Are you back on your previous medication, or are you and your doctor working on a different plan moving forward?
Take care of yourself, and please keep me posted on how you're doing.
Chris

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cathy5161 | @cathy5161 | Jul 28 3:26pm

In reply to @santosha "Hi @cathy5161 Thanks for those updates. I'm sorry to get this news from your trial! You..." + (show)

Hi - I feel much better thank you. I had to keep taking my current seizure meds during the trial. I see my neurologist/autoimmune specialist next week. Would like to try slowly weaning off the XCOPRI and stopping the Actemra shots. Not sure what her position will be. I'm convinced im over-medicated and still not clear which is worse - the seizures or medial side effects. Interesting the trial took me off the trial med cold turkey...and had no sense of issues associated with quick withdrawal.

Chris Gautier, Volunteer Mentor | @santosha | Jul 30 9:09am

In reply to @cathy5161 "Hi - I feel much better thank you. I had to keep taking my current seizure..." + (show)

Hi @cathy5161
I'm so glad to hear you're feeling much better in such a short period of time!
I didn't realize you had to continue your previous medications during the trial. What a double dose, huh? It sounds like you were overmedicated.
You wondered what's worse - seizures or medication side effects. Both are terrible, but in my opinion, medications should provide far more benefits than harm, which clearly wasn't happening.
You mentioned something that I could not fully understand: "Interesting the trial took me off the trial med cold turkey...and had no sense of issues associated with quick withdrawal". Do I understand correctly that you didn't experience any withdrawal symptoms when they stopped the trial medication abruptly?
I'm curious to hear what your neurologist and autoimmune specialist have to say. If you don't mind sharing their opinions, I'd be interested to know their perspective.
Chris

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cathy5161 | @cathy5161 | Jul 30 10:32am

Hi - no real withdrawal effects. 30 mg I believe is considered a fairly low dose and the mechanism of this med is supposed to be very different than more conventional epilepsy meds. However, the long and short of it is as first line guinea pig, I gave consent to follow the study's protocol. Have an appt with my dr next week and I'll mention it.

This is the studies protocol

cathy5161 | @cathy5161 | Jul 30 10:58am

In reply to @cathy5161 "Hi - no real withdrawal effects. 30 mg I believe is considered a fairly low dose..." + (show)

Ignore last sentence.

Scary episode on vacation in late June. Rare mistake of taking all epilepsy at midnight, then again at 7 am. Didn't realize it until I started feeling really weird. Got off couch and was absolutely impossible to walk a straight line. Lasted 3 hours. Kept calling the 24 hour trial emergency line but no one answered (it was Sunday). Very disturbing and scary. I skipped Sunday night's meds.