Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lundbeck LLC
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- Percent Reduction in Number of Drop Seizures.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
详细描述
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have been <11 years of age at the onset of LGS
- •Subject must have LGS
- •Subject must be on at least 1 stable dose AED
- •Parent or caregiver must be able to keep an accurate seizure diary
排除标准
- •Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
- •Subject has had an episode of status epilepticus within 12 weeks of baseline
- •Subject has had an anoxic episode requiring resuscitation within 1 year of screening
- •Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
- •Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
- •If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
- •If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
- •Subject has taken corticotropins in the 6 months prior to screening
- •Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
- •If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events
研究组 & 干预措施
Clobazam Low Dose
干预措施: Clobazam Low Dose (Drug)
Clobazam High Dose
干预措施: Clobazam High Dose (Drug)
结局指标
主要结局
Percent Reduction in Number of Drop Seizures.
时间窗: 4-week baseline period and 4-week maintenance period
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
时间窗: 4-week baseline period and the 4-week maintenance period
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
次要结局
- Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.(4-week baseline period and 4-week maintenance period)
- Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.(Week 7)