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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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Start Date
December 1, 2009
Primary Completion Date
February 1, 2011
Completion Date
March 1, 2011
Last Updated
April 22, 2011
42
ESTIMATED participants
alpha-tocopherolquinone (A0001)
DRUG
alpha-tocopherolquinone (A0001)
DRUG
placebo
DRUG
Lead Sponsor
Penwest Pharmaceuticals Co.
NCT02497534
NCT02316314
NCT07095062
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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