Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

PHASE3CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Friedreich's Ataxia
Interventions
DRUG

Idebenone

All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).

DRUG

Placebo

Trial Locations (6)

Unknown

Innsbruck

Bonn

München

Tübingen

Groningen

WC 1N 3BG

The National Hospital, University College London, London

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT01303406 - Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI) | Biotech Hunter | Biotech Hunter