Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

NCT ID: NCT00824512

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-10-31

Brief 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

Conditions

Friedreich Ataxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

EGb 761® 120 mg

Group Type: EXPERIMENTAL

EGb 761 120 mg

Intervention Type: DRUG

EGb 761® 120 mg bid, orally for 12 to 14 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 1 tablet BID, orally for 12 to 14 weeks

Interventions

EGb 761 120 mg

EGb 761® 120 mg bid, orally for 12 to 14 weeks

Intervention Type: DRUG

Placebo

Placebo 1 tablet BID, orally for 12 to 14 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Hospital Necker Enfants Malades

Paris, , France

Countries

France

Other Identifiers

2007-005371-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2-39-00240-133

Identifier Type: -

Identifier Source: org_study_id