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

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

March 31, 2011

Conditions
Friedreich's Ataxia
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.

Trial Locations (1)

19104

The Children's Hospital of Philadelphia, Philadelphia

Sponsors
All Listed Sponsors
lead

Penwest Pharmaceuticals Co.

INDUSTRY

NCT01035671 - Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia | Biotech Hunter | Biotech Hunter