Status:
COMPLETED
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
Lead Sponsor:
Ipsen
Conditions:
Friedreich Ataxia
Eligibility:
All Genders
12-22 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00824512
Start Date
June 1 2008
End Date
October 1 2011
Last Update
April 7 2020
Active Locations (1)
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1
Hospital Necker Enfants Malades
Paris, France, 75015