A Phase 3, Randomized, Double-blind, Parallel, Placebo-controlled, Multicenter Study, With Optional Open-label Continuation, Of The Efficacy And Safety Of Vanquix(tm) Auto-injector (Diazepam Injection) For The Management Of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Medical Intervention To Control Episodes Of Acute Repetitive Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 234
- 试验地点
- 85
- 主要终点
- Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)
研究概览
简要总结
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
干预措施: Placebo (Drug)
Diazepam
During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, as a deep intramuscular injection in the mid to outer thigh. Additional doses were permissible during the Open-label Period. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
干预措施: Vanquix Auto-Injector (Diazepam Injection) (Drug)
结局指标
主要结局
Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)
时间窗: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period
时间窗: From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period
An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.
次要结局
- Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period(Assessments completed at the end of each treated episode of ARS in the Double-blind Period)
- Mean Score on Physician Global Treatment Assessment During the Double-blind Period(At Visit 2 and subsequent visits in the Double-blind Period)
- Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period(From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period)
- Mean Score on Caregiver Global Treatment Assessment During the Open-label Period(Assessments completed at the end of each treated episode of ARS in the Open-label Period)
- Mean Score on Physician Global Treatment Assessment During the Open-label Period(From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination)
- Number of Participants Requiring Rescue Medication During the Open-label Period(From 15 minutes to 12 hours after study drug administration during the Open-label Period)
- Number of Participants Requiring Emergency Department Visits During the Open-label Period(From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period)
- Number of Participants Requiring Rescue Medication During the Double-blind Period(From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period)
- Number of Participants Requiring Emergency Department Visits During the Double-blind Period(From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period)
- Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period(From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period)