A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Episodic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 990
- 试验地点
- 182
- 主要终点
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
研究概览
简要总结
In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
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Trial duration: 52 to 55 weeks;
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Screening period: 4 to 5 weeks;
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Treatment duration: 4 treatments, each about 12 weeks apart; and
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Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
- •Participant age < 50 years at the time of migraine onset;
- •Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and
- •During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.
排除标准
- •Diagnosis of chronic migraine;
- •Diagnosis of other primary headache types, except tension-type headache, which is permitted;
- •Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;
- •Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
- •Currently taking > 1 prescribed drug for the preventive treatment of migraine;
- •Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.
研究组 & 干预措施
Xeomin Dose A
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
干预措施: Xeomin (Drug)
Placebo
Placebo-controlled period: Placebo injections at pericranial and cervical points.
Extension period: Xeomin injections at pericranial and cervical points (dose A)
干预措施: Placebo (Drug)
Xeomin Dose B
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
干预措施: Xeomin (Drug)
Placebo
Placebo-controlled period: Placebo injections at pericranial and cervical points.
Extension period: Xeomin injections at pericranial and cervical points (dose A)
干预措施: Xeomin (Drug)
结局指标
主要结局
Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
时间窗: Baseline to month 6
次要结局
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B(Baseline to month 6)
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A(Baseline to month 6)
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B(Baseline to month 6)
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A(Baseline to month 6)
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B(Baseline to month 6)
- Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4)(Baseline up to 12 months)
- Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection(Baseline to month 6)
- Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period(Month 6)