NCT05685225撤回2 期
Safety and Efficacy of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Single-Site, Phase 2 Randomized Trial
Allodynic Therapeutics, Inc2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of subjects with acute migraine who achieved freedom from pain after dosing
研究概览
简要总结
- This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage.
- 4 visits
- Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.
详细描述
This study evaluating naltrexone-acetaminophen in 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 75 years, inclusive.
- •At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition 17 (ICHD-3).
- •Migraine onset before age 50 years.
- •Read, write, and speak English
- •BMI Higher than 20 and Lower than 34
- •The female subject who is premenopausal or postmenopausal less than one year or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using two methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study medication (e.g., barrier with an additional spermicidal, intra- uterine device, hormonal contraception). Male subjects must be surgically sterile (the procedure occurred greater than 6 months before the Screening Visit) or commit to using two different birth control methods during the study and for 28 days after the last dose of the study medication.
排除标准
- •Pregnant or nursing women or those planning a pregnancy.
- •Used opioids (including methadone and buprenorphine), barbiturate-containing medications, muscle relaxants, or benzodiazepines within 3 months prior to screening.
- •Used any recreational drugs in the past 3 months.
- •Use of medications to treat headaches more than 10 days per month in the past 3 months or use of any pain medication for other pain syndromes for more than 10 days per month.
- •Uncontrolled cardiovascular or cerebrovascular disease or a history of heart failure, atrial fibrillation, or myocardial infarction.
- •Uncontrolled hypertension (systolic/diastolic blood pressure ˃ 140/90 mmHg) or diabetes.
- •Immediate family members or same household members participating in the study.
- •Site personnel, their friends, and family.
- •Abnormal laboratory or ECG results.
- •Aspartate transaminase (AST/SGOT), alanine transaminase (ALT/SGPT), or alkaline Phosphatase ≥ 1.5 x Upper Limit of Normal (ULN). creatinine ≥ 1.5 x ULN.
- •BBB or intraventricular conduction defect with a QRS duration ≥ 150 msec. ST-T wave abnormalities.
- •Hemoglobin < 10 g/dL
- •Neutrophil count ≤ 1000/μL
- •Cholesterol ≥ 300 mg/dL
- •Triglycerides ≥ 500 mg/dL Additional exclusion criteria may apply.
结局指标
主要结局
Proportion of subjects with acute migraine who achieved freedom from pain after dosing
时间窗: 2 hours after dosing
Freedom from pain is defined as the absence of headache pain from moderate or severe pain at baseline, without the use of rescue medication. The pain is measured on a 4-point scale, with 0 indicating no pain, 1 for mild pain, 2 for moderate pain, and 3 for severe pain.
Proportion of subjects with acute migraine who achieved freedom from migraine's Most Bothersome Symptoms (MBS) after dosing
时间窗: 2 hours after dosing
MBS freedom is defined as the absence of the identified Most Bothersome Symptom (MBS), which can be nausea, photophobia, or phonophobia. The MBS is measured on a binary scale, either absent or present.
次要结局
- Proportion of subjects with acute migraine who achieved pain relief(2 hours after dosing)
- Proportion of subjects with acute migraine who achieved freedom from photophobia(2 hours after dosing)
- Proportion of subjects with acute migraine who achieved freedom from phonophobia(2 hours after dosing)
- Proportion of subjects with acute migraine who achieved freedom from nausea(2 hours after dosing)
- Proportion of subjects with acute migraine who achieved sustained pain relief from 2 to 24 hours(2 to 24 hours)
- The proportion of subjects with acute migraine who achieved sustained pain freedom from 2 to 24 hours(2 to 24 hours)
- Functional disability at 2 hours(2 hours after dosing)
- Functional disability at 24 hours(24 hours after dosing)
- Use of rescue medications within 24 hours(within 24 hours)
- Pain relapse within 48 hours(within 48 hours)
研究者
研究点 (2)
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