Oral Radicava Trial

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ChesterB

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Hello Everybody!

I began the phase 3 trial At Wake Forest Monday morning. I was first in line so I served as the guinea pig for the doctors and staff, as it was new to them and they have to follow the protocol. All went well and I got the first dose, along with some lab work and an EKG. I was sent home with a 2-week supply of the drug and an iPhone app to track daily dosing. I’ve not had any serious problems taking it so far, just some stomach upset.

Anyone else want to share their experiences?
 

lisa g

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Curious, do you take it on the same schedule as infusing it?
 

ChesterB

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Yes, it’s exactly the same.
 

lisa g

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Did you at any point take Radicava by infusion? I'm finishing my 2nd cycle by infusion and so far I haven't had any side effects.
 

ChesterB

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No, I held off the infusions for 8 months waiting for the clinical trial to start. COVID-19 delayed things.
As far as side effects go, I have to add fatigue to the list. I dose at 5:00 A.M., and it lasts for about half a day.
 

affected

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I wonder if it is possible to dose at night and get to sleep the effects off?
 

Anjum nazir

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Oh...I have been waiting for oral edaravone since long...I had my infusions for 6 months and it helped me a lot....

I just want to know whether oral and infused forms have the same efficacy...

As per research edaravone retards progression by 33 percent...only problem is infusion method and it is painful..

How long will it take the trail to finish..
 

lgelb

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Just to be clear, that 33% is an aggregate number and based on narrow inclusion/exclusion criteria via Japanese trials. The real world is another matter. You can search for other edaravone/Radicava threads using the top right link, where we have discussed this and PALS have reported their experiences with the IV version.

To answer your question, often, we find that oral drugs don't have the same efficacy, but we don't know yet. The current trial is set to close in June. However, Mitsubishi plans to present interim 24-week data to the FDA as part of fast track status, and evidently has hopes (or wants its stockholders to) for approval next year.
 

lisa g

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Anjum Nazir, why did you stop infusions after 6 months if I might ask? I was on the fence about whether to take the infusions or not in the end I decided to try it and I'm glad I did. As far as it being painful that would depend on how you were having it administered. At first I wanted to have it done by a peripheral IV line until I was told it had to be changed every 72 hours,that would be 4 different lines for the first dose. I opted for a pic line for the first dose to make sure I tolerated the medication that way the line was put in once and could constantly be accessed. I experienced no side effects, so I had a power port placed. Best decision and painless.

I wonder of the effectiveness of a pill to that of an infusion going directly into the bloodstream. I guess we'll have to wait for the findings from the trial.
 

Anjum nazir

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I am a witness to the fact that the only drug which made me feel good and delayed progression as kept on measuring my thighs and calf was radicava... unfortunately I am from Kashmir India and here neuros feel it is to be administered for six months only...

Also my blood vessels are no longer visible ...it is tough finding a line and on administering the dose the Veselka get ruptured...leaving no lines on arms ...
So I left it....I did it in 2018 through 2019 for six months ....

Since then there has been considerable thigh muscle loss and unable to climb stairs or walk longer distances....mine is a lower motor neurone predominant disease...

Can I still use it and in absence of a clear line what should I do can you please teach me in lay man's words how to keep on using the same line without it getting blocked...
 

lisa g

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A port is a permanent line that is surgically placed under the skin just below your collarbone. With this you are always accessed at the same area. It makes getting the infusions easily.
 

Babycakes

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Hey, I’ll chime in... I’m over halfway through the trial. You have to fast 8 hours before and 1-2 hours after the dose for proper absorption. I haven’t had any side effects to speak of. The first cycle I noticed some fatigue, but not after that.
My progression is slow, so it’s hard to know how it’s affecting me. But I can say my FVC has remained 100% and my FRS score has maybe dropped 1 point over the last 6 months (I think average progression is 1 point a month..feel free to correct me if I’m wrong).
I’ve heard they want to do an additional study with 3 dose options (ie. standard dose daily, traditional 14 day cycles, max dosing). If I’m able to, I’ll keep taking it orally after the study.
How has it gone for you Chester?
 
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