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Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI) | Clinical Trials | Clareo Health

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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

NCT01303406•Santhera Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
•Patients who in the opinion of the investigator are able to comply with the requirements of the study
•Body weight ≥ 25kg
•Negative urine pregnancy test

Exclusion Criteria

•AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
•Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
•Parallel participation in another clinical drug trial
•Pregnancy or breast-feeding
•Abuse of drugs or alcohol
•Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study

Locations (6)

Innsbruck, Austria

Bonn, Germany

München, Germany

Tübingen, Germany

Groningen, Netherlands

The National Hospital, University College London

London, United Kingdom

Key Dates

Start Date

April 1, 2011

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

March 9, 2016

Enrollment

ACTUAL participants

Conditions

Friedreich's Ataxia

Interventions

Idebenone

DRUG

Placebo

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: March 9, 2016Data 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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Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

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.

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

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

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