Radicava question

[Babycakes]

Hey,
I started the oral Radicava trial 2 weeks ago. It’s structured similar to IV infusions...14 on, 14 off then 10 of 14 on and 14 off.

Today is my first day without drug and I’m exhausted. It could be a number of things...but I wondered if this is common during the drug free period.

Btw I’m happy to answer any questions about the study...i Believe they are still recruiting. I hope it’s successful, it would be a huge game changer.
Kim
(I’m LMN limb onset. Super slow progression. Diagnosed 9/2018)

 

[Bestfriends14]

Hello,
My husband does have less energy between infusions, so I think that that is normal. I have heard others with the same symptoms, as well. Kim, if you could PM me, I would love to know more about the oral study. We are currently in Palm Desert, but are from Canada, so maybe they would take him considering we have a home here and could easily commute to the study.

Thanks : )

 

[Gorby]

I think must be this one: Safety Study of Oral Edaravone Administered in Subjects With ALS - Full Text View - ClinicalTrials.gov

Exciting news.

 

[Babycakes]

I think must be this one: Safety Study of Oral Edaravone Administered in Subjects With ALS - Full Text View - ClinicalTrials.gov

Exciting news.

yep this is the trial. It’s open label, so no placebo group and lasts around one year. In person visits are once a month it seems like.

 

[lgelb]

After this, which as noted is primarily a safety study, their plan as of last year (summary attached) was to do a final study testing three regimens: an oral 2-week on/off cycle, daily oral dosing at the equivalent IV dose, and a daily “high-dose” treatment, before filing for FDA approval for the regimen(s) shown most safe/tolerable/effective.

 

[Babycakes]

After this, which as noted is primarily a safety study, their plan as of last year was to do a final study testing three regimens: an oral 2-week on/off cycle, daily oral dosing at the equivalent IV dose, and a daily “high-dose” treatment, before filing for FDA approval for the regimen(s) shown most safe/tolerable/effective.

I wasn’t aware of the future trial plans...and the clinic wasn’t either. I asked about if the drug would be offered after the trial and they never mentioned it. That sucks...it’d be a couple years then before market.