Clenbuterol Trial

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KevinM

Distinguished member
Joined
Mar 30, 2019
Messages
374
Reason
PALS
Diagnosis
06/2019
Country
US
State
FL
City
Tallahassee
I saw on another website that they just posted the Duke University Clenbuterol trial result summary page from the small study overseen by Dr. Bedlack. It was a six month trial that started with 25 participants (no placebo, non randomized) and the disappointing news is that 14 dropped out before the end of the trial because of side effects (cramps, tremors, insomnia, palpitations). A number of tested therapies seem to come with intolerable side effects that will limit their use if ever approved, unless different dosing amounts or other mitigating drugs can be found to counteract these reactions.

However, all 11 of those who fully participated showed slowing of progression from their previous rate, with 5 of those showing zero progression. Overall, there was about a 70% reduction in progression in the 11 participants over the 6 month period. This follows the positive results from the other very small 2006 Italian study that first piqued Bedlack’s interest in the drug.

I think most all us know the pitfalls and potentially misleading data from a small study with no control group over a short period of time, especially using the FRS-R scores. A larger, lengthy study would be next if funding can be secured, but most PALS don’t have that kind of time. As with NurOwn, AMX35, TRegs, and a couple of other promising treatments, I know there are many that would be at the front of the line to try these, with or without additional studies. ALS trials and the regulatory approval process are both deeply flawed. Kevin
 
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