Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

PHASE3CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Friedreich's Ataxia
Interventions
DRUG

Idebenone

Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day

DRUG

Idebenone

Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day

DRUG

Placebo

Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.

Trial Locations (2)

19104

The Children's Hopsital of Philadelphia, Philadelphia

90095-1769

David Geffen School of Medicine, UCLA, Los Angeles

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT00537680 - Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia | Biotech Hunter | Biotech Hunter