EUCTR2005-002088-98-IT进行中（未招募）不适用
A multicentre, multinational, double-blind, randomised, parallel group, placebo controlled trial of ethyl-EPA ethyl-Icosapent in patients with Huntington s Disease - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Written informed consent.Aged 35 or older of either genderHas clinical features of Huntington s Disease HD and a confirmatory family history of HD, and/or a CAG repeat expansion greater than or equal to 36. Maximal dystonia score of 2 or less in both trunk and extremities items.Chorea score of at least 2 in at least one extremity item.Maximal bradykinesia score of 2 or less in each of the items body, pronation/supination and finger tappingAble to travel to the assessment centre and judged by the Investigator as likely to be able to continue to travel for the duration of the trial.Not considered to have major depression as defined in the DSM-IV-TRNot considered at risk of suicide must not score positive for item A9 on the DSM-IV-TR .Treatment with neuroleptics including atypical neuroleptics is excluded, except when taken at a stable dose for 4 weeks or more prior to visit 1.Not taking tetrabenazine, omega 3 supplements, anticoagulant medication, steroids other than topical preparations , selenium supplements 55mcg/day, magnesium supplements 150mg/day including NMDA antagonists , lithium, antiepileptic medication and benzodiazepines. However, benzodiazepines are allowed if taken on a regular basis at a low dose for insomnia e.g. valium 5mg, temazepam 10mg, diazepam and lorazepam 1mg taken at night.
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Unable to give written informed consent.Requires 24 hour care and usually bedridden Unlikely to comply with trial visit schedule or with trial medication due to irritability, symptoms of depression or other reason s Diagnosis of major depressive disorder as defined in the DSM-IV-TRScore positive for item A9 on the DSM-IV-TRSevere intercurrent illness which, in the opinion of the Investigator, may put the patient at risk when participating in the trial or may influence the results of the trial or affect the patients ability to take part in the trial.Clinically significant, abnormal, baseline laboratory result s , which in the opinion of the Investigator affect s the patients suitability for the trial e.g. abnormal TSH.Females who, in the opinion of the Investigator, have the potential of childbearing but are not taking adequate contraceptive precautions; or who are pregnant or lactating.Alcohol and / or drug abuse as defined in theDSM IV criteria for substance abuse - applies to alcohol and / or any illicit drug, including cannabis within the last 12 months.Omega 3 supplementation within 4 weeks of visit 1 and throughout the trial period.Treatment with tetrabenazine current or within 4 weeks of visit 1.Treatment with neuroleptics including atypical neuroleptics except when taken at a stable dose for 4 weeks or more prior to visit 1Treatment with benzodiazepines on a regular basis within 8 weeks of visit 1, except when used at a low doses for insomnia e.g. valium 5mg, temazepam 10mg, diazepam and lorazepam 1mg at night.Treatment with steroids other than topical preparations current or within 4 weeks of visit 1.Selenium supplementation 55mcg/day within 4 weeks of visit 1.Magnesium supplementation 150mg/day, riluzole or NMDA antagonists memantine and amantadine within 4 weeks of visit 1.Treatment with lithium medication current or within 6 months of visit 0.Treatment with antiepileptic medication current or within 6 months of visit 0.Have participated in another interventional clinical trial or taken Investigational Medication in the last 3 months.Have participated in any clinical trial with ethyl-EPA.Known allergy to any ingredients of the trial medication or placebo.Currently taking anticoagulants.
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