NCT05399459已完成3 期
Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine 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
- 897
- 试验地点
- 50
- 主要终点
- Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
研究概览
简要总结
This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment 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
- Treatment
- 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 migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following:
- •Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- •Migraine attacks, on average, lasting about 4-72 hours if untreated.
- •Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.
- •Ability to distinguish migraine attacks from tension/cluster headaches.
- •Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening period.
- •Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening Period.
- •Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months prior to the Screening Visit, and if 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.
- •History of 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 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 at least 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, 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 a 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 alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.
- •Participation in any other investigational clinical trial while participating in this clinical trial.
研究组 & 干预措施
Rimegepant 25 mg
Experimental
Single dose of 25 mg orally disintegrating tablet of rimegepant
干预措施: Rimegepant 25 MG (Drug)
Rimegepant 75 mg
Experimental
Single dose of 75 mg orally disintegrating tablet of rimegepant
干预措施: Rimegepant 75 MG (Drug)
Placebo
Placebo Comparator
Matching placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
时间窗: 2 hours post-dose
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Formal statistical hypothesis testing was planned only for rimegepant 75 mg group with controlling type 1 error by the prespecified hierarchical gate-keeping procedure. For rimegepant 25 mg, no formal statistical hypothesis testing was conducted for any outcome measures as pre-specified in Statistical Analysis Plan (SAP).
次要结局
- Percentage of Participants With Pain Relief at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants With Ability to Function Normally at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-Dose(Within 24 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose(2 to 48 hours post-dose)
- Percentage of Participants With Absence of Photophobia at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-Dose(2 to 24 hours post-dose)
- Percentage of Participants With Freedom of Phonophobia at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants With Freedom From Nausea at 2 Hours Post Dose(2 hours post-dose)
- Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-Dose(2 to 48 hours post-dose)
- Number of Participants With Serious AEs(From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks))
- Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose(2 to 24 hours post-dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-Dose(2 to 48 hours post-dose)
- Number of Participants With Adverse Events (AEs) by Intensity(From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks))
- Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Hematology(Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks])
- Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Serum Chemistry(Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks])
- Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Urinalysis(Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks])
研究者
研究点 (50)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of Liraglutide in Healthy Japanese Male VolunteersDiabetesDiabetes Mellitus, Type 2NCT01515592Novo Nordisk A/S24
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese VolunteersDiabetesDiabetes Mellitus, Type 2NCT01620463Novo Nordisk A/S32
已完成
1 期
Safety and Tolerability of Liraglutide in Healthy Japanese VolunteersHealthyDiabetesNCT01620476Novo Nordisk A/S24
已完成
1 期
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01620424Novo Nordisk A/S10
已完成
1 期
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069HealthyNCT01100047AstraZeneca63