NCT04804033终止2 期
A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1,753
- 试验地点
- 102
- 主要终点
- Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
研究概览
简要总结
The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 - 72 hours if untreated
- •Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit
- •Eight or more migraine days during the Observation Period
- •15 or more headache days during the Observation Period
- •One or more non-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 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.
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 screening).
- •Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.
- •Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.
- •Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
- •Body mass index > 33 kg/m2
- •History of gallstones or cholecystectomy.
- •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
研究组 & 干预措施
BHV-3500 200mg
Active Comparator
Zavegepant 200mg oral soft gel capsule.
干预措施: BHV-3500 (zavegepant) (Drug)
Placebo 200mg
Placebo Comparator
Matching placebo 200mg oral soft gel capsule.
干预措施: Placebo (Drug)
BHV-3500 100mg
Active Comparator
Zavegepant 100mg oral soft gel capsule.
干预措施: BHV-3500 (zavegepant) (Drug)
Placebo 100mg
Placebo Comparator
Matching placebo 100mg oral soft gel capsule.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
时间窗: Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)
A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\*(total number of migraine days through Month 3\[Weeks 1 to 12\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\[Weeks 1 to 12\] in the on-DBT efficacy analysis period).
次要结局
- Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase(OLE: Over 52 weeks of treatment)
- Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)(Entire DBT Phase: 12 weeks (Week 1 through 12))
- Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase(Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12))
- Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase(Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4))
- Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12)(Entire DBT Phase: 12 weeks (Week 1 through 12))
- Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12(DBT Phase: Baseline (before dose on Day 1), Week 12)
- Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12(DBT Phase: Baseline (before dose on Day 1), Week 12)
- Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase(DBT Phase: During 12 weeks of treatment)
- Number of Participants With Serious Adverse Events (SAEs): DBT Phase(DBT Phase: During 12 weeks of treatment)
- Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase(DBT Phase: During 12 weeks of treatment)
- Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase(DBT: During 12 weeks of treatment)
- Number of Participants With Moderate or Severe AEs: OLE Phase(OLE: During 52 weeks of treatment)
- Number of Participants With SAEs: OLE Phase(OLE: During 52 weeks of treatment)
- Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase(OLE: During 52 weeks of treatment)
- Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase(OLE: During 52 weeks of treatment)
- Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase(DBT: Over 12 weeks of treatment)
- Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase(OLE: Over 52 weeks of treatment)
- Number of Participants With Hepatic-related AEs by Intensity: DBT Phase(DBT Phase: During 12 weeks of treatment)
- Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase(DBT Phase: During 12 weeks of treatment)
- Number of Participants With Hepatic-related AEs by Intensity: OLE Phase(OLE: Over 52 weeks of treatment)
研究者
研究点 (102)
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