NCT00291733Unknown2 期
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial
1st Hospital of Social Security Services1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
研究概览
简要总结
Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.
Study objectives :
- To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
- To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.
- •Other inclusion criteria:
- •Patients between ages 30 and 80
- •Hoehn and Yahr stage of PD over IIb
- •Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication
- •LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV
- •Patient is willing to adhere to protocol requirements as evidence by written informed consent
排除标准
- •Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.
- •Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.
- •Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.
- •Patient has a low Mini-mental Examination MMSE score <25 or has a history of bipolar psychosis or schizophrenia.
- •Patient is unwilling to sign an informed consent or to comply with protocol requirements.
- •Patient is taking or has taken in the past month amantadine.
研究组 & 干预措施
1
Active Comparator
500mg levetiracetam for one week and 1000mg levetiracetam for one week
干预措施: Levetiracetam (Drug)
2
Placebo Comparator
placebo
干预措施: Placebo (Drug)
3
Active Comparator
After crossover arm 3 equals arm 1
干预措施: Levetiracetam (Drug)
4
Placebo Comparator
After crossover arm 4 equals arm 2
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries
时间窗: 24 hours
次要结局
- Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose.(24 hours)
研究者
研究点 (1)
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