NCT05399485已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 496
- 试验地点
- 44
- 主要终点
- Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase
研究概览
简要总结
This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- •Age of onset of migraines prior to 50 years of age.
- •Migraine attacks, on average, lasting 4 to 72 hours if untreated.
- •Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol).
- •4 or more migraine days during Observation Period.
- •Not more than 18 headache days during the Observation Period.
- •Ability to distinguish migraine attacks from tension/cluster headaches.
- •Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and the dose is not expected to change during the course of the study.
- •Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
排除标准
- •Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine.
- •Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit.
- •History of systemic use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- •Subject with a history of HIV disease.
- •Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
- •Uncontrolled hypertension, or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for 3 months prior to screening).
- •Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- •Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption.
- •The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
- •History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
- •Participation in any other investigational clinical trial while participating in this clinical trial.
研究组 & 干预措施
Rimegepant
Experimental
Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12
干预措施: Rimegepant (Drug)
Placebo
Placebo Comparator
Randomization Phase: one matching placebo every other day until week 12
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase
时间窗: Baseline, Week 9 to Week 12 of the DBT phase
Migraine day: 1) day of electronic diary (eDiary) efficacy data with a qualified migraine headache, defined as: Headache lasted for \>= 30 minutes and had 2 or more of following pain features: Unilateral and pulsating, moderate or severe pain intensity, worsen or avoid physical activity with one or more of the following associated symptoms: nausea, vomiting, both photophobia and phonophobia or 2) Acute migraine-specific medication day as eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or non-scheduled OL Rimegepant dosing day. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month \[Week 9 to 12\])/ (total number of efficacy data days in month \[Week 9 to 12\]).
次要结局
- Percentage of Participants With at Least 50% Reduction From Baseline in the Mean Number of Moderate to Severe Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase(Baseline, Week 9 to Week 12 of the DBT phase)
- Mean Change From Baseline in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)(Baseline, Week 1 to Week 12 of the DBT phase)
- Mean Change From Baseline in Number of Migraine Days Per Month From Week 1 to 4 of the DBT Phase(Baseline, Week 1 to Week 4 of the DBT phase)
- Mean Number of Acute Migraine-specific Medication Days Per Month From Week 9 to 12 of the DBT Phase(Week 9 to Week 12 of the DBT phase)
- Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) v 2.1 Role Function - Restrictive Domain Score at Week 12 of the DBT Phase(Baseline, Week 12 of the DBT phase)
- Mean Change From Baseline in the Migraine Disability Assessment Total Score (MIDAS) at Week 12 of the DBT Phase(Baseline, Week 12 of the DBT phase)
- Mean Change From Baseline in the EuroQol 5 Dimensions 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Week 12 of the DBT Phase(Baseline, Week 12 of the DBT phase)
- Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Serious Adverse Events (SAEs) in DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With SAEs in OLE Phase(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With AEs Leading to Discontinuation of Study Drug in DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With AEs Leading to Discontinuation of Study Drug in OLE Phase(From Day 1 of OL Rimegepant dosing up at Week 12 to Week 52 (40 weeks))
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Hematology Parameters(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Serum Chemistry Parameters(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Serum Chemistry Parameters(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Grade 3 to 4 Changes in DBT Phase: Urinalysis(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With Grade 3 to 4 Changes in OLE Phase: Urinalysis(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3* Upper Lower Limit of Normal (ULN) Concurrent With Total Bilirubin (TBIL) >2*ULN in DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With ALT or AST> 3* ULN Concurrent With TBIL >2* ULN in OLE Phase(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Hepatic-related AEs in the DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With Hepatic-related AEs in the OLE Phase(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
- Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the DBT Phase(From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks))
- Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the OLE Phase(From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks))
研究者
研究点 (44)
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