NCT01284556已完成3 期
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Phenobarbital as Adjunctive Therapy in Participants (> or = 17 to 70 Years Old) With Partial Onset Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 4
- 主要终点
- Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
研究概览
简要总结
Primary:
- to evaluate the efficacy of phenobarbital in reducing seizure frequency.
Secondary:
- to confirm dose response relationship,
- to assess the effects on Type I seizures,
- to assess the safety of phenobarbital
- to assess the drug tolerability.
详细描述
Primary:
-to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing seizure frequency in participants with partial onset seizures (Type I seizures; complex or simple with motor symptoms only) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve Stimulator (VNS)
Secondary:
- to confirm dose response relationship of 60 and 100 mg phenobarbital doses,
- to assess the effects of phenobarbital on Type I seizures,
- to assess the safety of phenobarbital
- to assess the tolerability of phenobarbital
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants from 17 to 70 years old;
- •history of Type I partial onset seizures (complex or simple with motor symptoms only);
- •participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
- •participants having at least eight Type I partial onset seizures during 8-week baseline period;
- •participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
- •participant has been on a stable dose of their current anti-epileptic treatment regime
排除标准
- •currently taking phenobarbital or primidone;
- •currently taking felbamate or vigabatrin;
- •history of prior allergic reaction to phenobarbital;
- •history of psychogenic seizures;
- •history or presence of status epilepticus;
- •history or presence of seizures occurring only in clusters;
- •participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;
- •history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- •presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
- •presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
- •history of porphyria;
- •presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;
- •history of alcohol or drug abuse within the year prior to screening;
- •participant who is known to be non-compliant;
- •participant who is male or female who refuses to use an acceptable form of contraception;
- •female who is pregnant or lactating or intends to become pregnant;
- •participant who has taken part in any investigational device or product within 2 months prior to the screening visit
研究组 & 干预措施
Placebo
Placebo Comparator
placebo tablets
干预措施: Placebo tablet (Drug)
60 mg group
Experimental
Patients titrated to 60mg phenobarbital for maintenance period, then titrated down.
干预措施: Phenobarbital (Drug)
100 mg group
Experimental
Patients titrated to 100mg phenobarbital maintenance period, then titrated down
干预措施: Phenobarbital (Drug)
结局指标
主要结局
Evaluate the efficacy of OD administration of 60 mg and 100 mg phenobarbital in reduction of seizure frequency
时间窗: 34 weeks with maximum 22-week exposure to phenobarbital
* determination of partial onset seizure frequency per week over the treatment period * comparison of average change in weekly seizure rate from baseline and maintenance period
次要结局
- Assess the effects of phenobarbital on Type I seizures(34 weeks with a maximum 22-week exposure to phenobarbital)
- Assess the safety of phenobarbital(34 weeks with a maximum 22-week exposure to phenobarbital)
- Assess the tolerability of phenobarbital(34 weeks with maximum 22-week exposure to phenobarbital)
- Confirm the dose response relationship of 60 mg and 100 mg phenobarbital doses(34 weeks with a maximum 22-week exposure to phenobarbital)
研究者
研究点 (4)
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