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| Sponsor: | Ipsen |
|---|---|
| Information provided by (Responsible Party): | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00824512 |
Purpose
The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia
| Condition | Intervention | Phase |
|---|---|---|
|
Friedreich Ataxia |
Drug: EGb 761 120 mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Phase II, Randomised, Double Blind Study Assessing the Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia |
| Enrollment: | 22 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: EGb 761® 120 mg |
Drug: EGb 761 120 mg
EGb 761® 120 mg bid, orally for 12 to 14 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo 1 tablet BID, orally for 12 to 14 weeks
|
Eligibility| Ages Eligible for Study: | 12 Years to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00824512 History of Changes |
| Other Study ID Numbers: | 2-39-00240-133, 2007-005371-34 |
| Study First Received: | January 15, 2009 |
| Last Updated: | November 29, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Ataxia Friedreich Ataxia Stress, Psychological Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Spinocerebellar Degenerations Cerebellar Diseases |
Brain Diseases Central Nervous System Diseases Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mitochondrial Diseases Metabolic Diseases Behavioral Symptoms |