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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00824512 |
The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Freidreich Ataxia
Condition | Intervention | Phase |
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Freidreich Ataxia |
Drug: EGb 761 120 mg bid Drug: Placebo 1 tablet BID |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomised, Double Blind Study Assessing the Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
EGb 761® 120 mg
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Drug: EGb 761 120 mg bid
EGb 761® 120 mg bid, orally for 12 to 14 weeks
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2: Placebo Comparator
Placebo 1 tablet
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Drug: Placebo 1 tablet BID
Placebo 1 tablet BID, orally for 12 to 14 weeks
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Ages Eligible for Study: | 12 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ipsen Recruitment Enquiries | clinical.trials@ipsen.com |
France | |
Hospital Necker Enfants Malades | Recruiting |
Paris, France, 75015 |
Study Director: | Dr Philippe Garnier | Ipsen |
Responsible Party: | Ipsen ( Philippe Garnier, Medical Development Director ) |
Study ID Numbers: | 2-39-00240-133 |
Study First Received: | January 15, 2009 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00824512 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Metabolic Diseases Spinal Cord Diseases Central Nervous System Diseases Mitochondrial Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias Signs and Symptoms |
Heredodegenerative Disorders, Nervous System Friedreich Ataxia Genetic Diseases, Inborn Ataxia Neurologic Manifestations Cerebellar Diseases Metabolic Disorder Spinocerebellar Degenerations |
Metabolic Diseases Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases Mitochondrial Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias |
Signs and Symptoms Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Friedreich Ataxia Ataxia Neurologic Manifestations Cerebellar Diseases Spinocerebellar Degenerations |