Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.
详细描述
The study is designed to answer frequently asked questions when clinicians replace existing 1,4-benzodiazepine to Onfi, as follows:
- What should be the optimal equivalent doses for conversion?
- How quickly should it be converted?
- Would there be significant improvement of seizure control?
- Should we expect difference in tolerability? If so, what are common adverse events?
- Would the tolerance to the therapeutic effect differ with Onfi after conversion?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to the initial study visit.
- •Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure control.
- •Takes at least one additional Anti-epileptic drug besides benzodiazepine.
- •Age 18-70 years, inclusive.
- •In opinion of investigator, can be safely treated with Onfi.
- •Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures, during the 8-week baseline period prior to study entry.
- •Able to communicate effectively with study personnel and considered reliable, able, willing, and cooperative with regard to complying with protocol-defined requirements, including completion of study diary.
排除标准
- •Clinically relevant current illness or history of that may interfere with the subject's ability to complete the study as determined by the investigator.
- •History of status epilepticus within 6 months prior to the initial study visit.
- •History of suicidal attempts or suicidal ideation within 12 months of initial visit.
研究组 & 干预措施
clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
干预措施: clobazam (Onfi) (Drug)
clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
干预措施: Initial conversion and titration (Drug)
clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
干预措施: Conversion schedule - Week 1 (Drug)
clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
干预措施: Conversion schedule - Week 2 (Drug)
clonazepam conversion to clobazam (Onfi)
Subject's clonazepam will be converted to clobazam (Onfi). This is an open label study without placebo control.
干预措施: Conversion schedule - Week 3 (Drug)
结局指标
主要结局
Efficacy
时间窗: 28 days
Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days.
次要结局
- Tolerability(Weeks 6 - 52 after medication conversion)
- Retention(52 weeks)