NCT03461757已完成3 期
BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine
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
- 1,811
- 试验地点
- 63
- 主要终点
- Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
研究概览
简要总结
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind to Sponsor, Investigator and Participant
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, Beta version [1] 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
- •Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the 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 the Screening Visit and maintains this requirement during the Screening Period.
- •Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit 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 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 (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
- •Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), 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 of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known 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.
- •Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
- •Participation in any other investigational clinical trial while participating in this clinical trial
研究组 & 干预措施
Arm 1: Rimegepant 75 mg
Experimental
Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
干预措施: Rimegepant (Drug)
Arm 2: Placebo
Placebo Comparator
Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
时间窗: 2 hours post-dose
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
时间窗: 2 hours post-dose
MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.
次要结局
- Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose(From 2 hours up to 24 hours post-dose)
- Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose(From 2 hours up to 24 hours post-dose)
- Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose(90 minutes post-dose)
- Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants With Pain Relief at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Pain Relief at 90 Minutes Post-dose(90 minutes post-dose)
- Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose(90 minutes post dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose(From 2 hours up to 24 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose(90 minutes post-dose)
- Percentage of Participants With Pain Relief at 60 Minutes Post-dose(60 minutes post-dose)
- Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose(24 hours post-dose)
- Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose(From 2 hours up to 24 hours post-dose)
- Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose(60 minutes post-dose)
- Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose(2 hours post-dose)
研究者
研究点 (63)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy Study in Adult Subjects With Acute MigrainesMigraine, With or Without AuraNCT03235479Pfizer1,485
已完成
3 期
Safety and Efficacy in Adult Subjects With Acute MigrainesMigraine, With or Without AuraNCT03237845Pfizer1,499
已完成
2 期
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in AdultsMigraineNCT03732638Pfizer1,590
已完成
3 期
Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of MigraineAcute MigraineNCT04574362Pfizer1,648
招募中
3 期
Randomized Study in Children and Adolescents With Migraine: Acute TreatmentPediatric MigraineNCT04649242Pfizer2,100