Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia
Status: | Archived |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | December 2009 |
End Date: | June 2010 |
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, 28 Day, Three-arm, Parallel Group Study of A0001 in the Treatment of Subjects With Friedreich's Ataxia
This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001
given twice daily for 28 days. Potential subjects will be screened first to determine
eligibility, after which they will be randomized to receive either a high dose of A0001, a
low dose of A0001 or placebo for 28 days.
Eligible subjects will return within 21 days of screening for the baseline visit and
randomization to one of three potential treatments. The subjects will be required to take 3
capsules of study medication in the morning with a morning meal and 3 capsules of study
medication at night with an evening meal for 28 days. Additional visits to the clinic are
planned for Day 14 and Day 28, at which time a number of clinical and biochemical
assessments will be done.
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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