Sokol. You are right on track. Could CDER and Anavex be crafting the first CNS Basket Trial?
It's great that Ihub catalogs our old posts.....saves a lot of stubby finger work.
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"How important is controlling seizures, tremor and involuntary movement to our drug trials?"
From a Previous post
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Bio, Polar. Coordination with the FDA has been ANAVEX's focus for more than the last few months. It is assured that Dr Fadiran, who was involved with implementation of the 21stCCA during his last years at the FDA, and our trials experts on the SAB are working in lock step with their counterparts at OND and CDER in the design of our precision medical trials. Commissioner Gottlieb has commented on the Center of Excellence for Oncology and the intent for the FDA to stand-up a similar COE for Neuroscience. I believe, that while the Neuroscience COE is still in the formative stage, there is a body of expertise within the FDA that is championing CNS drugs and working with promising companies like ANAVEX to get 21stCCA trials going.
IMHO they are looking at commom endpoints for an overarching trial architecture for Rett, Fragile X, Angelmans, and Infantile Spasms. Although the mechanism of the diseases vary, look at the some of the common symptoms (possible trial endpoints) that are similar.
Fragile X
- delay in talking/intellectual disability
- anxiety
- hyperactive behavior/uncontrolled hand movements
- seizures and tremors
Infantile Spasms/West Syndrome
- severe myclonic convulsions
- nodding attacks convulsions of the throat and neck muscles
- jackknife convulsive attacks of the body
Angelmans
-development delays/lack of speech
- seizures
-delayed motor skills/delayed ability to walk/balance issues
Rett Syndrome
- inability to speak, walk or eat
- breathing difficulties
- constant involuntary hand movements
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