NCT00043901已完成4 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 87
- 主要终点
- % change from Baseline in average monthly PGTC seizure frequency
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weigh at least 13kg.
- •Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
- •Currently being treated with an antiepileptic drug(s) (AED).
- •Benzodiazepines are allowed with some frequency restrictions.
- •Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
- •History of primary generalized tonic-clonic seizures with no focal onset.
- •Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
- •Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
- •Females must agree to acceptable form of birth control.
排除标准
- •A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
- •Have Lennox-Gastaut syndrome.
- •Currently using or has previously used the drug being studied.
- •Is abusing alcohol and/or other substance(s).
- •Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
- •Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
- •Follows the ketogenic diet.
- •Is planning surgery to control seizures during the study.
- •Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
- •Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
结局指标
主要结局
% change from Baseline in average monthly PGTC seizure frequency
次要结局
- Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
研究者
研究点 (87)
Loading locations...
相似试验
终止
2 期
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute StrokeStrokeNCT00073476Pfizer300
已完成
2 期
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)Urinary IncontinenceOveractive BladderNCT00290563Vyne Therapeutics Inc.557
已完成
2 期
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout FlaresGoutNCT00610363Regeneron Pharmaceuticals83
已完成
3 期
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)Chronic Kidney DiseaseNCT02110901Proteon Therapeutics349
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe PsoriasisModerate to Severe Chronic Plaque PsoriasisNCT00601107Genzyme, a Sanofi Company111