Neuroleptic and Huntington Disease. Comparison of : Olanzapine, la Tetrabenazine and Tiapride. A Multicentric, Randomised, Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- the Independence scale
研究概览
简要总结
Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.
详细描述
We proposed a randomized controlled trial, including 180 patients, in 3 groups: Olanzapine, Tetrabenazine and Tiapride, followed during 12 months. These treatments have been selected according their profile and their frequency of use.
The principal criteria is the Independence scale, one of the functional scales of the Unified Huntington's Disease Rating Scale, the only validated scale in HD.
Secondary criteria will assess motor,functional, psychiatric and cognitive functions, metabolic parameters, tolerance and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.
- •HD diagnosed with abnormal number of CAG repeats: 38 ≤ nucleotide expansion (CAG) (amendment n°5 suppressed the limit ≤ 48)
- •Neuroleptic Prescription required.
- •Age ≥ 18 (amendment n°5 suppressed the limit ≤ 65 years old)
- •Patient gave its written consent
- •Realization of medical examination and a Electroencephalogram
排除标准
- •Severe cognitive impairment or neuropsychiatric troubles.
- •Existing diabetes.
- •Neuroleptic prescription forbidden according to the neurologist decision.
- •Current participation to another clinical trial.
- •No drug compliance to previous treatment.
- •No national health insurance affiliation
研究组 & 干预措施
1
Olanzapine Mylan
干预措施: Olanzapine (Drug)
2
Xenazine
干预措施: Xenazine (Drug)
3
Tiapridal
干预措施: Tiapridal (Drug)
结局指标
主要结局
the Independence scale
时间窗: at 12 month
次要结局
- motor scale(at 3, 6, 9 and 12 month)
- cost(at 3, 6, 9 and 12 month)
- Function scale (TFC and Functionnal Appreciation Scale)(at 3, 6, 9 and 12 month)
- Psychiatric scale(at 3, 6, 9 and 12 month)
- cognitive function scale(at 3, 6, 9 and 12 month)
- tolerance(at 3, 6, 9 and 12 month)
- metabolic parameters(at 3, 6, 9 and 12 month)