A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 47
- 主要终点
- Pain-free status at 2 hours post treatment
研究概览
简要总结
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.
Part 1: Approximately 20 weeks (includes screening and double-blind treatment).
- Screening will be performed based on the inclusion exclusion criteria specified in the study protocol.
- Randomize approximately 288 subjects into the double-blind crossover phase.
Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (OLE).
Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in both the double-blind and the OLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of ischemic or vasospastic heart disease, arrhythmias associated with accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another 5HT1 agonist, ergots or ergotamine-containing medications.
- •Any medical condition, including severe hepatic impairment, which, in the opinion of the investigator, may put the subject at increased risk with exposure to zolmitriptan, or may interfere with the safety or efficacy assessments.
- •Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
- •Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
- •Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute treatment of migraine
- •Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.
研究组 & 干预措施
Run-in - Placebo - ZNS - OLE
After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
干预措施: ZNS (Drug)
Run-in - ZNS - Placebo - OLE
After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
干预措施: Placebo ZNS (Drug)
Run-in - ZNS - Placebo - OLE
After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
干预措施: ZNS (Drug)
Run-in - Placebo - ZNS - OLE
After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
干预措施: Placebo ZNS (Drug)
结局指标
主要结局
Pain-free status at 2 hours post treatment
时间窗: 2 hours post-dose
Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
次要结局
- Proportion of subjects who achieve pain-free status at 24 hours post-dose(24 hours post-dose)
- Sustained headache response at 24 hours post-dose(24 hours post-dose)
- Headache response at 24 hours post-dose(24 hours post-dose)