NCT01303406

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

A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia. The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities.

Conditions

• Friedreich's Ataxia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-02-24
• Last updated: 2016-03-09
• Results posted: 2016-03-09

Locations

6 sites across 4 countries: Austria, Germany, Netherlands, United Kingdom