NCT07792681尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study Evaluating the Efficacy and Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults
Brise Pharmaceuticals Co., Ltd.114 个研究点 分布在 1 个国家目标入组 2,079 人开始时间: 2026年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,079
- 试验地点
- 114
- 主要终点
- Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of BR005-036C 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
- 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
- •Male or female Participants aged 18 years or older.
- •Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year.
- •Onset age of migraine shall be less than 50 years old.
- •At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit.
- •Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.
- •Patients 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 study entry.
排除标准
- •Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia.
- •Patient with clinically significant cardiovascular, cerebrovascular, hematological, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological or psychiatric disorders; patient with other confounding acute or chronic pain syndromes, dementia, epilepsy, or other diseases (other than migraine) that may interfere with study assessments.
- •Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis.
- •Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.
- •Abnormal electrocardiogram findings at screening: QTcF >450 msec for male subjects; QTcF >470 msec for female subjects.
- •Patient with uncontrolled hypertension.
- •History of alcohol or substance abuse within 6 months prior to screening.
- •Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin >1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- •Use of CGRP receptor antagonists within 1 month prior to screening or randomization; use of anti-CGRP or anti-CGRP-receptor monoclonal antibodies within 6 months prior to screening or randomization.
- •Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).
研究组 & 干预措施
BR005-036C Dose 1
Experimental
干预措施: BR005-036C (Drug)
BR005-036C Dose 2
Experimental
干预措施: BR005-036C (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose
时间窗: 2 hours post-dose
Percentage of Participants with Freedom from Pain at 2 hours post-dose
时间窗: 2 hours 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 Pain Freedom from 2 to 48 hours post-dose(From 2 hours up to 48 hours post-dose)
- Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose(From 2 hours up to 24 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 2 hours post-dose(2 hours post-dose)
- Number of Participants With Adverse Events (AEs)(On-treatment period was from the administration of study intervention and through the EOT visit, up to 9 days)
研究者
研究点 (114)
Loading locations...
相似试验
招募中
2 期
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaTardive DyskinesiaNCT07365462Neurocrine Biosciences100
招募中
3 期
A Study of DA-302168S in Participants With Overweight/ObesityNCT07629544Chendu DIAO Pharmaceutical Group CO., LTD.840
Unknown
3 期
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and or Serious InfectionsCTRI/2025/02/080276Novotech Clinical Research India Private Limited150
尚未招募
3 期
Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsules in Patients With Early-Onset Parkinson's DiseaseParkinson's Disease (PD)Parkinson Disease 6, Early-OnsetNCT07741045Hangzhou PhecdaMed Co., Ltd.300
尚未招募
不适用
A Clinical Study to Assess the Safety and Efficacy of Scalp Cream in patients with DandruffCTRI/2025/07/090946Blossom Microbiotics LLC34