Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia

Ipsen

Status and phase

Completed

Phase 2

Conditions

Friedreich Ataxia

Treatments

Drug: EGb 761 120 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

2-39-00240-133

2007-005371-34 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

22 patients

Sex

All

Ages

12 to 22 years old

Volunteers

No 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