NCT05452239已完成4 期
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 140
- 主要终点
- Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4
研究概览
简要总结
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.
Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.
详细描述
The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
- •The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- •The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
- •The participant has had an onset of migraine diagnosis at ≤50 years of age.
排除标准
- •The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
- •The participant has a diagnosis of acute or active temporomandibular disorders.
- •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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- •The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
- •The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Eptinezumab
Experimental
Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.
干预措施: Eptinezumab (Drug)
Placebo
Placebo Comparator
Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.
干预措施: Eptinezumab (Drug)
Placebo
Placebo Comparator
Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.
干预措施: Placebo (Drug)
结局指标
主要结局
Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4
时间窗: Baseline, Weeks 1 - 4
A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.
次要结局
- Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12(Baseline, Weeks 1 - 4 and Weeks 1 - 12)
- Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH)(Weeks 1 - 4 and Weeks 1 - 12)
- Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2(Baseline, Weeks 1 - 2)
- Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12(Baseline, Weeks 1 - 4 and Weeks 1 - 12)
- Open-label Period: Change From Baseline in MMDs at Weeks 13-16, 17-20, and 21-24(Baseline, Weeks 13-16, 17-20, and 21-24)
- Open-label Period: Change From Baseline in the Number of MHDs at Weeks 13-16, 17-20, and 21-24(Baseline, at Weeks 13-16, 17-20, and 21-24)
- Open-label Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM Nor MOH at Weeks 13 to 24(Weeks 13 - 24)
- Open-label Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 13-16, 17-20, and 21-24(Baseline, Weeks 13-16, 17-20, and 21-24)
- Open-label Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 13-16, 17-20, and 21-24(Baseline, Weeks 13-16, 17-20, and 21-24)
- Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for CM at Weeks 1 to 4 and Weeks 1 to 12(Weeks 1 - 4 and Weeks 1 - 12)
- Placebo-controlled Period: Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH at Weeks 1 to 4 and Weeks 1 to 12(Weeks 1 - 4 and Weeks 1 - 12)
- Placebo-controlled Period: Change From Baseline in MMDs With Use of Acute Headache Medication at Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Placebo-controlled Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Open-label Period: Change From Baseline in Monthly Days With Triptan or Ergotamine Medication Use at Weeks 13-16, 17-20, and 21-24(Baseline, Weeks 13-16, 17-20, and 21-24)
- Placebo-controlled Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or Non-steroidal Anti-inflammatory Drug (NSAID) Medication Use at Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Open-label Period: Change From Baseline in Monthly Days With Individual Non-opioid Analgesics or NSAID Medication Use at Weeks 13-16, 17-20, and 21-24(Baseline, Weeks 13-16, 17-20, and 21-24)
- Placebo-controlled Period: Change From Baseline in Monthly Days With Combination Non-opioid Analgesics Medication Use at Weeks 1 to 12(Baseline, Weeks 1 - 12)
- Placebo-controlled Period: Number of Participants With Migraine on the Day After Dosing(Day 1)
- Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MMDs at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Percentage of Participants With ≥50% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Percentage of Participants With ≥75% Reduction From Baseline in MHDs at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Change From Baseline in Percentage of Migraine Attacks With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Change From Baseline in Percentages of Headache Episodes With Severe Pain Intensity at Weeks 1 to 4 and Weeks 1 to 12(Baseline to Weeks 1 - 4 and 1 - 12)
- Placebo-controlled Period: Patient Global Impression of Change (PGIC) Score at Weeks 4 and 12(Weeks 4 and 12)
- Open-label Period: PGIC Score at Week 24(Week 24)
- Placebo-controlled Period: Most Bothersome Symptom (MBS) Score at Week 12(Week 12)
- Open-label Period: MBS Score at Week 24(Week 24)
- Placebo-controlled Period: Change From Baseline in Headache Impact Test (HIT-6) Total Score at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Open-label Period: Change From Baseline in HIT-6 Total Score at Week 24(Week 24)
- Placebo-controlled Period: Change From Baseline in Modified Migraine Disability Assessment (mMIDAS) Total Score at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Open-label Period: Change From Baseline in mMIDAS Total Score at Week 24(Baseline, Week 24)
- Placebo-controlled Period: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Open-label Period: Change From Baseline in MSQ v2.1 Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24(Baseline, Weeks 24)
- Placebo-controlled Period: Change From Baseline in Euroqol 5 Dimension - 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Open-label Period: Change From Baseline in EQ-5D-5L VAS Score at Week 24(Week 24)
- Placebo-controlled Period: Change From Baseline in Work Productivity and Activity Impairment: Migraine (WPAI:M) Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12(Baseline, Week 12)
- Open-label Period: Change From Baseline in WPAI:M Sub-scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24(Baseline, Week 24)
- Placebo-controlled Period: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale (Depression and Anxiety) Scores at Weeks 4 and 12(Baseline, Weeks 4 and 12)
- Open-label Period: Change From Baseline in HADS Subscale (Depression and Anxiety) Scores at Week 24(Baseline, Week 24)
- Placebo-controlled Period: Treatment Satisfaction Questionnaire for Medicine - 9 Items (TSQM-9) Score at Weeks 4 and 12(Weeks 4 and 12)
- Open-label Period: TSQM-9 Score at Week 24(Baseline, Week 24)
- Placebo-controlled Period: Migraine Specific Health Care Resource Utilization (HCRU) - Visits to a Family Doctor/General Practitioner at Baseline and Week 12(Baseline and Week 12)
- Placebo-controlled Period: Migraine Specific HCRU - Visits to a Specialist at Baseline and Week 12(Baseline and Week 12)
- Placebo-controlled Period: Migraine Specific HCRU - Number of Emergency Department Visits Due to Migraine at Baseline and Week 12(Baseline and Week 12)
- Placebo-controlled Period: Migraine Specific HCRU - Number of Hospital Admissions Migraine at Baseline and Week 12(Baseline and Week 12)
- Placebo-controlled Period: Migraine Specific HCRU - Total Number of Participants With Overnight Hospital Stays Due to Migraine at Baseline and Week 12(Baseline and Week 12)
- Open-label Period: Migraine Specific HCRU - Visits to a Family Doctor/General Practitioner at Week 24(Week 24)
- Open-label Period: Migraine Specific HCRU - Visits to a Specialist at Week 24(Week 24)
- Open-label Period: Migraine Specific HCRU - Number of Participants With Emergency Department Visits Due to Migraine at Week 24(Week 24)
- Open-label Period: Migraine Specific HCRU - Number of Participants With Hospital Admissions Due to Migraine at Week 24(Week 24)
- Open-label Period: Migraine Specific HCRU - Number of Participants With Overnight Hospital Stays Due to Migraine at Week 24(Week 24)
研究者
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