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Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients | Clinical Trials | Clareo Health

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

A Phase III Open-Label, Single Group Extension Study of the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

NCT00697073•Santhera Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

Detailed Description

The study involves 6 clinic visits.

Eligibility

Age

8 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
•Body weight ≥ 25kg/55 lbs
•Negative urine pregnancy test
•Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion Criteria

•Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
•Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
•Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
•Parallel participation in another clinical drug trial
•Past or present history of abuse of drugs or alcohol
•Pregnancy or breast-feeding

Locations (2)

David Geffen School of Medicine, UCLA

Los Angeles, California, United States

The Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

July 11, 2023

Enrollment

ACTUAL participants

Conditions

Friedreich's Ataxia

Interventions

Idebenone

DRUG

Biomarkers in Friedreich's Ataxia

NCT02497534

Friedreich's Ataxia

View study

RECRUITING

Characterization of the Cardiac Phenotype of Friedreich's Ataxia (FRDA)

NCT02316314

Friedreich's Ataxia

View study

RECRUITINGNA

Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.

NCT07095062

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Biomarkers in Friedreich's Ataxia

Characterization of the Cardiac Phenotype of Friedreich's Ataxia (FRDA)

Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.

An Open-label Study of the Effects of Acetyl-L-Carnitine on Cardiovascular Outcomes in Friedreich's Ataxia

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

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