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Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia. A 3 Month, Phase II, Randomised, Double Blind, Placebo Controlled, Parallel Group Clinical Study.

NCT00824512•Ipsen

View on ClinicalTrials.gov

Summary

The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia

Eligibility

Age

12 - 22 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Friedreich ataxia diagnosis confirmed by evidenced mutation expansion of Frataxin gene
•Ambulatory patient, with depressed tendon reflexes and pyramidal syndrome associated or not to a loss of position or vibration senses or dysarthria
•Patient able to perform the tests of the study

Exclusion Criteria

•Severe cardiac disease as assessed by echocardiography performed at least within 6 months before screening or during the wash out period (4 weeks)
•Absolute contra-indication to Nuclear Magnetic Resonance spectroscopy(NMR) examination: iron and any magnetic objects implanted in the whole body, e.g. some neurostimulators, cardiac pace-makers, vascular clips and other implanted orthopaedic prosthesis
•Patient who did not deplete at baseline phosphocreatine (PCr) pool by more than 30 % during the exercise bout
•Any continuous use of the following forbidden medications:
•other antioxidant such as idebenone, coenzyme Q, vitamin E/C taken for less than 4 weeks prior study treatment start (ie for antioxidant drugs a mandatory wash-out period of 4 weeks prior study drug start has to be observed),
•any other vasodilators
•tranquilizer such as benzodiazepine, meprobamate or buspirone, and/or antidepressant (only one), at non stable dose

Locations (1)

Hospital Necker Enfants Malades

Paris, France

Key Dates

Start Date

June 1, 2008

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

April 7, 2020

Enrollment

ACTUAL participants

Conditions

Friedreich Ataxia

Interventions

EGb 761 120 mg

DRUG

Placebo

DRUG

A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

NCT06054893

Friedreich Ataxia

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RECRUITINGNA

Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia

NCT06692296

Friedreich Ataxia

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

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: April 7, 2020Data 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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Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

Inclusion Criteria

Exclusion Criteria

A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia

Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

NAD+ and Exercise in FA

Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia

Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia