NCT04437199已完成2 期
A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine
Cerecin10 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年12月17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
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 10
- 主要终点
- Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants with frequent migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
- •Participants who have frequent (episodic or chronic) migraine with or without aura, for at least 1 year, according to the International Classification of Headache Disorders version 3 beta (ICHD 3-beta), age at time of onset must be <50 years.
- •Participants must have a certain number of migraine headaches days per month, as confirmed by the baseline measurement period.
- •Use of one allowed migraine prophylactic is permitted if the participant has been on a stable dose for at least 2 months prior to the screening.
- •Participants must have failed (no therapeutic response) 1-4 migraine prophylactic treatments.
- •The participant is able to tolerate a 12.5g dose of AC-SD-03 (containing 5g of tricaprilin) as per sentinel dose challenge at the Baseline Visit.
- •From Visit 2 to Visit 3 (baseline measurement period), the participant has sufficient compliance (at least 80%) with daily eDiary headache entries.
排除标准
- •In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the participant at risk.
- •Use of barbiturates (and/or butalbital-containing analgesics) or opioids (and/or opioid-containing analgesics) for migraine acute treatment ≥ 4 days per month on average and/or in the last month prior to Screening Visit.
- •Use in the last 3 months prior to Screening Visit of CGRP agents, Botox injections, TENS, cranial nerve blocks, trigger-point injections, acupuncture, CBD-containing products, infusion therapy.
- •Current use, or use within 3 months of Visit 2 (baseline), of Axona® or other MCT-containing products (such as coconut oil). Use of MCT-containing products is not allowed at any time during trial participation.
- •Current use, or use within 3 months prior to Screening, of a ketogenic diet, low-carb diet, intermittent fasting (including the 5:2 diet). Ketogenic diets, low-carb diet, intermittent fasting (including the 5:2 diet) are not allowed during the study.
研究组 & 干预措施
AC-SD-03
Active Comparator
Tricaprilin SD formulation, twice daily. Administered orally
干预措施: Tricaprilin (Drug)
AC-SD-03P
Placebo Comparator
Placebo formulation, twice daily. Administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
时间窗: 12 weeks
Number of migraine headache days using headache diary parameters
次要结局
- Change from baseline in the number of migraine headache days during Month 1 (ΔMDMth1) and Month 2 (ΔMDMth2) of treatment and overall, from Months 1-3(4, 8, 12 weeks)
- Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3(4, 8, 12 weeks)
- Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3(4, 8, 12 weeks)
- The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3(4, 8, 12 weeks)
研究者
研究点 (10)
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