Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 892
- 试验地点
- 138
- 主要终点
- Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
研究概览
简要总结
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
详细描述
The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks).
The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
- •The participant has a migraine onset of ≤50 years of age.
- •The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- •The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
- •The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
- •For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
- •For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
- •The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
- •The participant has a history of either previous or active use of triptans for migraine.
排除标准
- •The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
- •The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
- •The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
- •The participant has a diagnosis of acute or active temporomandibular disorder.
- •The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- •The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
- •The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Placebo
Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
干预措施: Placebo (Drug)
Eptinezumab 100 mg
Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
干预措施: Eptinezumab (Drug)
Eptinezumab 300 mg
Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
干预措施: Eptinezumab (Drug)
结局指标
主要结局
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
时间窗: Baseline, Weeks 1 - 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
次要结局
- Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24(Baseline, Weeks 13 - 24)
- Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24(Baseline, Weeks 13- 24)
- Change From Baseline in the HIT-6 Score at Week 24(Baseline, Week 24)
- Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12(Baseline, Week 12)
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24(Baseline to Weeks 13 - 24)
- Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24(Baseline to Weeks 13 - 24)
- Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12(Baseline to Weeks 1 - 12)
- Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Most Bothersome Symptom (MBS) Score at Week 12(Week 12)
- Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24(Baseline, Weeks 13 - 24)
- Patient Global Impression of Change (PGIC) Score at Week 12(Week 12)
- PGIC Score at Week 24(Week 24)
- Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Percentage of Participants With Migraine on the Day After First Dosing(Day 1)
- HCRU: Number of Emergency Department Visits Due to Your Migraine(Week 12)
- Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12(Baseline, Week 12)
- Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12(Baseline, Week 12)
- Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24(Baseline, Week 24)
- Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12(Baseline, Week 12)
- Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24(Baseline, Week 24)
- Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72(Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72)
- Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24(Baseline, Week 24)
- Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner(Week 12)
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72(Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72)
- Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72(Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72)
- Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score(Baseline to Week 12)
- Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score(Baseline to Week 24)
- HCRU: Visits to a Specialist(Week 12)
- HCRU: Number of Hospital Admissions Due to Migraine(Week 12)
- HCRU: Total Number of Overnight Hospital Stays Due to Migraine(Week 12)
- Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72(Baseline, Weeks 36, 48, 60, and 72)