CTRI/2011/08/001976已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 7
- 主要终点
- The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phase
研究概览
简要总结
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This is an adjunctive (add-on) therapy in adult subjects with partial onset seizures with or without secondary generalization. This study is a randomized, double-blind, placebo-controlled, parallel group multi-center trial. This compares the efficacy of 2 different dosages of pregabalin CR (165 mg and 330 mg) dosed once daily as compared to placebo when used as adjunctive (add-on) therapy in subjects requiring adjunctive therapy in partial onset epilepsy. This study was conducted at 7 sites in India with 32 subjects of which 24 subjects have entered into treatment. The study is completed and the sites are closed out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure) 2.Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs .
- •subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study.
排除标准
- •1.Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome) 2.Status epilepticus within one year prior to screening.
结局指标
主要结局
The primary endpoint will be the log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the double blind maintenance treatment phase
时间窗: Week 0 to week 14
次要结局
- 1.Evaluation for safety using adverse event data, medical history, PHQ 8, laboratory data, physical exams, vital signs, neurological exams, electrocardiograms, and suicidality assessment(Screening to Week 15)
- 2.Responder rate (proportion of subjects who have a greater than or equal to 50% reduction in partial seizure rate from baseline during the double blind maintenance treatment phase compared to the 8 week baseline (screening) seizure phase).(Screening to Week 15)
- 3.The percentage change in 28 day partial seizure rates summarized by treatment group(Screening to Week 15)
- 4.Frequency of secondary generalized tonic clonic seizures (SGTC).(Screening to Week 15)
- 5.Log-transformed 28 day SGTC rate for all SGTCs collected during the double blind maintenance treatment phase.(Screening to Week 15)
- 6.SGTC responder rate.(Screening to Week 15)
- 7.Changes from baseline in the anxiety and depression subscale scores of the Hospital Anxiety and Depression Scale (HADS) scores.(Baseline to Week 14)
- 8.Change from baseline in Medical Outcomes Study Sleep Scale (MOS Sleep Scale) subscale scores.(Baseline to Week 14)
- 9.Global scores on the patient rated Benefit, Satisfaction, and Willingness to Continue Measure (BSW).(Baseline to Week 14)
研究者
研究点 (7)
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