NCT06603623已完成2 期
Phase 2 Double-Blind, Randomized, Placebo Controlled, Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 647
- 试验地点
- 60
- 主要终点
- Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
研究概览
简要总结
This study is designed to identify at least one dose of BHV-2100 that is safe and effective in reducing headache pain and other symptoms in the 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with 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,19 including the following:
- •2-8 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
- •Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period.
- •Participants on prophylactic migraine medication are permitted to remain on therapy they have been on a stable dose for at least 3 months prior to the Screening Visit.
排除标准
- •Participants with a history of basilar migraine or hemiplegic migraine.
- •Participants who have taken medication for acute treatment of headache (including triptans, ergotamine, opioids, acetaminophen, NSAIDs, or combination analgesics) on 10 or more days in any of the 3 months prior to screening.
- •Participants who have used a neuromodulation device for migraine treatment over the preceding 3 months before screening.
- •History of chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.), or individuals who have received anti-HCV treatment within 6 months prior to Screening.
- •Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. participants 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, participants can be included who have stable hypertension and/or stable diabetes for at least 3 months prior to being enrolled). A single blood pressure measurement of greater than 150 mm Hg systolic or 100 mm Hg diastolic after 10 minutes of rest is exclusionary.
- •Participant has a current diagnosis of major depression, other pain syndromes (e.g. chronic pelvic pain, chronic regional pain syndrome, fibromyalgia), psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- •Participant has a history of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etc.), or other disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.
- •Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong CYP3A4 inhibitors or inducers.
- •Participant is on or has a recent history (past 30 days) of concomitant use of moderate/strong p-gp or BCRP inhibitors.
研究组 & 干预措施
BHV-2100 75 mg
Experimental
干预措施: BHV-2100 (Drug)
BHV-2100 150 mg
Experimental
干预措施: BHV-2100 (Drug)
Placebo
Placebo Comparator
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 are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
时间窗: 2 hours post-dose
MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose
次要结局
- Percentage of Participants With Pain Relief at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Return to Normal Function at 2 Hours Post-dose(2 hours 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 Sustained Pain Freedom From 2 to 24 Hours Post-dose(From 2 hours up to 24 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 Freedom From Phonophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose(2 hours post-dose)
- Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose(24 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(From 2 hours up to 48 hours post-dose)
- Observed Plasma concentration in Patients After a Single Dose of BHV-2100(At 2, 8, and 24 hours post-dose)
- Number of Participants with Deaths, Serious AEs (SAEs), and moderate or severe AEs(Up to 11 weeks)
- Number of Subjects with Clinically Significant Laboratory Abnormalities(Up to 11 weeks)
研究者
研究点 (60)
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