NCT00824512已完成2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Creatine Rephosphorylation Rate Post Exercise
研究概览
简要总结
The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EGb 761® 120 mg
Experimental
干预措施: EGb 761 120 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Creatine Rephosphorylation Rate Post Exercise
时间窗: 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.
次要结局
- Perfusion-time Integral During the First 9 Minutes Post Exercise.(Baseline (Week 0) to Week 12)
- Muscle Reoxygenation Rate Post Exercise.(Baseline (Week 0) to Week 12)
- Developed Force During the Exercise Bout(Baseline (Week 0) to Week 12)
- Metabolism Efficacy Index(Baseline (Week 0) to Week 12)
- International Cooperative Ataxia Rating Scale [ICARS] (Total Score)(Baseline (Week 0) to Week 12)
- Peak Post Exercise Perfusion(Baseline (Week 0) to Week 12)
- Time to Peak Perfusion(Baseline (Week 0) to Week 12)
- ICARS (Posture and Gait Disturbance Score)(Baseline (Week 0) to Week 12)
- Muscle Trophicity: Maximum Cross Section of Muscle(Baseline (Week 0) to Week 12)
- Normalised Work Developed During the Exercise(Baseline (Week 0) to Week 12)
- ICARS (Kinetic Function Score)(Baseline (Week 0) to Week 12)
- ICARS (Speech Disorders Score)(Baseline (Week 0) to Week 12)
- ICARS (Oculomotor Disorders Score)(Baseline (Week 0) to Week 12)
- Timed 25-foot Walk Test(Baseline (Week 0) to Week 12)
- Nine Hole Peg Test (Dominant Hand)(Baseline (Week 0) to Week 12)
- Nine Hole Peg Test (Nondominant Hand)(Baseline (Week 0) to Week 12)
- Visual Assessment Scale (VAS) of Global Impression - Parents(Baseline (Week 0) to Week 12)
- Visual Assessment Scale (VAS) of Global Impression - Investigator(Baseline (Week 0) to Week 12)
- Choice Reaction Time Test- Reaction Time(Baseline (Week 0) to Week 12)
- Choice Reaction Time Test- Movement Time(Baseline (Week 0) to Week 12)
- Visual Assessment Scale (VAS) of Global Impression - Patient(Baseline (Week 0) to Week 12)
研究者
研究点 (1)
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