Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
This study is currently recruiting participants.
Verified by Ipsen, January 2009
First Received: January 15, 2009   No Changes Posted
Sponsored by: Ipsen
Information provided by: 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 Freidreich Ataxia


Condition Intervention Phase
Freidreich Ataxia
Drug: EGb 761 120 mg bid
Drug: Placebo 1 tablet BID
Phase II

Genetics Home Reference related topics: Friedreich ataxia Marinesco-Sjögren syndrome mitochondrial neurogastrointestinal encephalopathy disease
MedlinePlus related topics: Exercise and Physical Fitness Friedreich's Ataxia
Drug Information available for: EGB 761
U.S. FDA Resources
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

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Creatine rephosphorylation rate (sec-1) post-exercise using P-31 NMR spectroscopy [ Time Frame: Assessed at the baseline (W0) and W12. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-exercise skeletal muscle perfusion (ml/min/100 g of tissue) [ Time Frame: Assessed at the baseline (W0) and W12 ] [ Designated as safety issue: No ]
  • Peak post exercise perfusion (ml/mn/100 g of tissue) [ Time Frame: Assessed at the baseline (W0) and W12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Assessed at the baseline (W0) and W12 ] [ Designated as safety issue: Yes ]

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
1: Experimental
EGb 761® 120 mg
Drug: EGb 761 120 mg bid
EGb 761® 120 mg bid, orally for 12 to 14 weeks
2: Placebo Comparator
Placebo 1 tablet
Drug: Placebo 1 tablet BID
Placebo 1 tablet BID, orally for 12 to 14 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 PCr pool by more than 40 % 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824512

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
France
Hospital Necker Enfants Malades Recruiting
Paris, France, 75015
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Dr Philippe Garnier Ipsen
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009