amylyx

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Kristina1

Senior member
Joined
Jan 26, 2017
Messages
822
Reason
PALS
Diagnosis
03/2017
Country
US
State
MA
City
Grafton
I was in the amylyx trial which ended January 2nd. In this trial, only 1/3 of patients were on placebo. I did feel it was helping me. They are going to do a one year open label extension where everyone gets the real drug. They got it approved with the IRB but we are waiting on the drug itself (I guess they have to make it and send it to the trial sites?). So there has been a lapse.

I have not had the drug since January 2nd. In that time I have felt that my progression is speeding up/worsening. I did also get a port placed the same week that the trial ended, so maybe that stressed out my body and increased progression. But I do wonder if it's because I'm off the drug.

I'm curious to see if progression slows again once I'm back on the drug. Just thought I'd share.
 
Thanks for sharing. How long before you get the real thing? If it is a bit of time what about at least taking TUDCA?
 
From what they told me last, it should be any day now!
 
I hope you get back on it fast!

May I ask what kind of speedy progression you have experienced in the past few weeks?
 
Fingers crossed that you're back on it soon! How are you feeling today as opposed to when you were on the drug? Did the drug give you more energy and were there initial side effects when you started the drug?

Good luck with getting back on the drug ASAP!
 
Tillie, in the last few weeks I have lost several more fine motor skills, noticed a further decline in swallowing, increased difficulty in standing from sitting, and increased gait disturbance. None of these things are new- but they went from a very, very gradual decline to where, recently, I am noticing "wow, today compared to last week is notably worse" kind of thing.

Bestfriendstilthened- the drug did not give me more energy, I just felt that it was slowing my progression. Maybe it's all in my head like a placebo affect- but I did feel it was helping me stay at a really slow almost plateued rate. As to side effects- initially I had GI side effects that subsided after a week or 2. When they increased the dose the GI issues came back again, but then went away again after about a week. I also had some bouts of dizziness when drug dose was increased but that went away. And also, from the time drug was increased until the trial ended I had some irregularity of my periods, which was a known side effect of the drug already.
 
Any news on when you might get it back? It's frustrating that they didn't have things ready to roll over as soon as the trial finished. I think the human element of 'this is your actual life and body' gets lost or forgotten!

Thanks so much for explaining what has been happening with your progression - I totally get what you are saying, I remember those tiny daily losses!
 
they just emailed yesterday that it won't be until March. :(
 
So sorry. Unless the protocol forbids it get TUDCA
 
I asked, they said TUDCA was exclusion criteria on the original trial i participated in, and might exclude me from the open label extension if i start it now, but she wasn't positive, so she said not to do anything until she checks. so im waiting to hear back.
 
so sorry it's such a long wait
 
If you do that, you will not be eligible to continue with the trial, as it would skew the data for the open label extension.
 
Actually, they confirmed I CAN take TUDCA and remain eligible to enter the open label phase. My neuro double confirmed with the folks from amylyx to be absolutely sure. They said I just have to stop taking TUDCA at least 24 hours before the screening visit. So I just ordered some on amazon.
 
Great. Did they specify a dose or leave it up to you?
 
They said start with 500mg once per day for 2-3 weeks, then increase to twice daily if well tolerated. I noticed when I bought some online that it's pretty darn expensive!
 
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