NCT00175955已完成2 期
An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
研究概览
简要总结
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between ages 18 and 80 years
- •Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
- •Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
- •Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening
排除标准
- •Presence of any axis II condition within 6 months prior to screening
- •Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
- •Start of drugs-other than neuroleptics- that can cause dyskinesia
- •Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness
结局指标
主要结局
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
次要结局
- Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
- Effect on the primary psychiatric disorder
- Safety
研究者
研究点 (7)
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