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

ClinicalTrials.gov ID: NCT00537680

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Official title

A Phase III Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

Study identification

NCT ID: NCT00537680
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Santhera Pharmaceuticals; Industry
Enrollment: 70 participants

Conditions and interventions

Conditions

Friedreich's Ataxia

Interventions

Idebenone Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 8 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2007 (Type not available)
Primary completion: Apr 2009 (Actual)
Completion: Apr 2009 (Actual)
Last update posted: Jul 11, 2023

2007 – 2009

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
David Geffen School of Medicine, UCLA	Los Angeles	California	90095-1769	—
The Children's Hopsital of Philadelphia	Philadelphia	Pennsylvania	19104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00537680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 11, 2023 · Synced Nov 15, 2026