NCT05853900已完成不适用
A Randomized Double-blind, Parallel-Group, Virtual Study to Evaluate the Effectiveness and Safety of Two Digital Therapeutics in Late Adolescents and Adults for the Prevention of Episodic Migraine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- Change in MMD (Monthly Migraine Days)
研究概览
简要总结
Randomized study of two digital therapeutics for the prevention of episodic migraine
详细描述
The purpose of this randomized ReMMi-D trial is to evaluate the effectiveness and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
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
- •A participant will be eligible for entry into the study if all of the following criteria are met:
- •Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- •Lives in the United States.
- •Adult or late adolescent, 18 years of age or older at the time of informed consent.
- •Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- •The following will be physician-reviewed: Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition.
- •Age of onset of migraines prior to 50 years of age
- •Migraine attacks, on average, lasting 4-72 hours if untreated
- •Per participant report, 4-14 migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days)
- •Four to fourteen migraine days during the run-in period
- •Is currently managing migraines with ≥1 prescription acute treatment and/or prescription first or second-line preventive medications, as assessed by a physician.
- •Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or later or a smartphone with an Android operating system (OS) 11 or later and is willing to download and use the Study App required by the protocol.
- •Is willing and able to receive SMS text messages and push messages on their smartphone.
- •Is the owner of, and has regular access to, an email address.
- •Has regular access to the Internet via cellular data plan and/or wifi.
排除标准
- •A participant will not be eligible for study entry if any of the following criteria are met:
- •History of basilar migraine or hemiplegic migraine.
- •Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS).
- •Other pain syndromes (including trigeminal neuralgia), psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- •History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months (48 weeks) or having met DSM-V criteria for any significant substance use disorder within the past 12 months (48 weeks) from the date of the screening visit.
- •History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen, including opioids) or butalbital on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit or during the run-in period.
- •Currently taking a prescription anti-calcitonin gene-related peptide (CGRP) for either episodic or chronic migraine.
- •Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome.
- •Other significant episodic or chronic medical condition(s) that in the opinion of the Investigator, may confound the interpretation of findings to inform PDT development.
- •Failure to adhere with or inability to complete Study App inputs and onboarding activities during the run-in period. Participants who are not adherent during the run-in period are not eligible for study entry.
- •Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine indication.
- •Participation in any other investigational clinical study while participating in this clinical study.
结局指标
主要结局
Change in MMD (Monthly Migraine Days)
时间窗: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12).
次要结局
- Participants Who Have at Least a 50% Reduction From Baseline(Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12))
- Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8(Baseline (28-day Run-in Period) to Weeks 4 and 8)
- Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12)(Baseline to Weeks 4, 8, and 12)
- Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12(Baseline (28-day Run-in Period) to Weeks 4, 8 and 12.)
- Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12(Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12))
- Change From Baseline in the Mean Number of MMD Over 12 Weeks(Baseline (28-day Run-in Period) to Week 12)
- Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12(Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12))
- Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication(Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)Episodic MigraineHeadacheHeadache, MigraineMigraineNCT06004388Click Therapeutics, Inc.110
已完成
1 期
A Study of Gastric Delay in Migraine Patients (3207-003)Migraine DisordersNCT00548353Merck Sharp & Dohme LLC22
已完成
不适用
Adjunctive Treatment of Chronic Migraine Using an Oral Dental DeviceChronic Migraine, HeadacheNCT04871581ChairsideSplint.com25
招募中
不适用
Closed-loop RTMS for Short-term Migraine PreventionMigraine DisordersNCT06735768Brightmind.AI88
招募中
不适用
Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of MigraineMigraineNCT06170411Nu Eyne Co., Ltd.100
相关资讯
FDA Approves CT-132: First Digital Therapeutic for Episodic Migraine Prevention- The FDA has approved Click Therapeutics' CT-132 as the first prescription digital therapeutic for preventive treatment of episodic migraine in adults, offering a smartphone-based intervention alongside traditional treatments.
- Clinical trials demonstrated CT-132 significantly reduced monthly migraine days by approximately 3 days after 12 weeks, with a 0.9-day advantage over the control group (p=.005) and improvements in quality of life measures.
- The app-based therapy works by modulating dysfunctional neurocircuitry associated with migraine through behavioral techniques including cognitive behavioral therapy elements, targeting sensory, autonomic, and affective networks.last yearMigraine Treatment Advances: CGRP Inhibitors, Digital Therapeutics, and Novel Compounds Highlight 2024• The American Headache Society now recommends CGRP-targeting therapies as a first-line approach for migraine prevention, marking a significant shift in treatment strategy.
• Nerivio, a remote electrical neuromodulation device, received FDA approval for expanded use in pediatric patients aged 8 and older for acute migraine treatment.
• Clinical trials show promise for digital therapeutic CT-132 in reducing monthly migraine days, offering a novel non-pharmacological option for episodic migraine prevention.last year