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Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia

NCT01035671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-04-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

alpha-tocopherolquinone (A0001)

28 days of low dose (1.0 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.

DRUG

alpha-tocopherolquinone (A0001)

28 days of high dose (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.

DRUG

placebo

28 days of placebo oral capsules. Treatment taken twice daily with meals.

Sponsors & Collaborators

  • Penwest Pharmaceuticals Co.

    lead INDUSTRY

Principal Investigators

  • David Lynch, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01035671 on ClinicalTrials.gov