Efficacy of EGb761 120mg Bid Versus Placebo in Patients Suffering From Friedreich Ataxia. A 3 Month, Phase II, Randomised, Double Blind, Placebo Controlled, Parallel Group Clinical Study.

NCT00824512 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	Ipsen
Phase	Phase 2
Status	COMPLETED
Enrolment	22
Start date	2008-06
Completion	2011-10

Conditions

• Friedreich Ataxia

Interventions

• EGb 761 120 mg
• Placebo

Primary outcomes

• Creatine Rephosphorylation Rate Post Exercise — Baseline (Week 0) to Week 12
  Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.

Countries

France