They will enroll 15 patients in the 1b dose finding study and follow this up with a larger placebo controlled randomized phase 2 (60-90 patients) based on results.
Instead of calling it a phase 1, why couldn’t they make it a phase 2 trial with part A and part B like the 2A Alzheimer’s trial?
They used the 5 week Part A to assign dosage for the part B didn’t they?
My suspicion is that they may have required a smaller starting group because of the communication difficulties of the Rett girls. The Sullivan article seemed to imply that headache and dizziness were signs that MTD was close. Can these girls adequately relay that information? Perhaps they now have a more objective measure to determine MTD?
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