EUCTR2007-005371-34-FR进行中（未招募）1 期
EFFICACY OF EGb 761® 120 mg bid VERSUS PLACEBO IN PATIENTS SUFFERING FROM FRIEDREICH ATAXIAA 3 months, phase II, randomised, double blind, placebo-controlled, parallel groups, clinical study. - EGB 761 in FRIEDREICH ATAXIA
BEAUFOUR IPSEN PHARMA0 个研究点目标入组 22 人开始时间: 2007年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Friedreich ataxia diagnosis confirmed by evidenced mutation expansion of frataxin gene,
- •2) Age from 12 to 20 years,
- •3) Ambulatory patient, with depressed tendon reflexes and pyramidal syndrome associated or not to a loss of position or vibration senses or dysarthria,
- •4) Patient able to perform the tests of the study,
- •5) Patient affiliated to a social security scheme,
- •6) Patient signed consent form or both parents’ signatures for children < 18 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non inclusion Criteria
- •Related to cardiac status:
- •1) Contra-indication to idebenone interruption as assessed by cardiac examination and echocardiography within 6 months or during the wash out period (4 weeks),
- •2) Severe cardiac disease as assessed by echocardiography performed at least within 6 months before screening or during the wash out period (4 weeks),
- •Related to NMR examination:
- •3) 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,
- •4) Relative contraindications to MNR examination: amagnetic object implanted in the legs (which could induce artefacts), claustrophobia, pregnancy,
- •5) Patient who did not deplete at baseline PCr pool by more than 40 % during the exercise bout.
- •Related to medication use:
- •6) 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.
- •7) Tranquilizer such as benzodiazepine, meprobamate or buspirone, and/or antidepressant (only one), at non stable dose (These concomitant drug could be accepted if taken at stable dose ie the dose is the same since at least 8 weeks, without any changes planned during the study),
- •8) Any disease with potential impairment of drug absorption,
- •9) known hypersensitivity to any of the tested drug or related compounds,
- •10) Patient treated with any unlicensed drug within the previous 30 days,
- •11) Patients suffering from congenital galactosemia, glucose or galactose malabsorption syndrome, lactase deficiency (as EGB761® contains lactose).
- •Other non inclusion criteria
- •12) Childbearing potential, young women without effective contraception,
- •13) Life expectancy < 1 year (whatever the cause),
- •14) Patient previously included in this study,
- •15) Patient unable or unwilling to comply fully with the protocol.
研究者
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