NCT06004388已完成3 期
A Randomized, Double-Blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics for the Prevention of Episodic Migraine in Late Adolescents and Adults Currently Receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Monthly Migraine Days (MMDs)
研究概览
简要总结
Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
详细描述
The purpose of this randomized trial is to evaluate the efficacy 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 who are receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
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 per participant self-report:
- •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 at the time of informed consent.
- •Able to read and understand the English informed consent form.
- •The following will be investigator-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 (ICHD), 3rd Edition:
- •i. Age of onset of migraines prior to 50 years of age
- •ii. Migraine attacks, on average, lasting 4-72 hours if untreated
- •iii. Per participant report, 4 or more migraine days per month within the last 3 months prior to the Screening Visit (a month is defined as 28 days)
- •iv. Four to fourteen migraine days during the run-in period
- •Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy for the preventive or acute treatment of episodic or chronic migraine during the 3 months prior to screening.
- •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 specified eDiary and 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.
- •Understands the use of and interest in the eDiary and the Study App during the screening period and the baseline visit (Day 1).
排除标准
- •A participant will not be eligible for study entry if any of the following criteria are met per participant self-report:
- •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 current 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-5 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.
- •Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome.
- •Other significant acute 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 eDiary 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
研究组 & 干预措施
ReMMiD-C Therapeutic Arm A
Experimental
Mobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
干预措施: Click Digital Therapeutic (Device)
ReMMiD-C Therapeutic Arm B
Experimental
Mobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
干预措施: Click Digital Therapeutic (Device)
结局指标
主要结局
Change in Monthly Migraine Days (MMDs)
时间窗: Baseline to Week 12
Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12
次要结局
- Proportion of Patients with Decrease in MMDs(Baseline to Week 12)
- Change in MMDs at Weeks 4 and 8(Baseline to Weeks 4 and 8)
- Change in Mean MMDs(Baseline to Week 12)
- Change in Migraine Medication Use (dose)(Run-in to Weeks 9-12)
- Change in Migraine Medication Use (frequency)(Run-in to Weeks 9-12)
- Change in Migraine Questionnaire(Baseline to Weeks 4, 8 and 12)
- Change in Average Headache Severity(Run-in to Weeks 9-12)
- Change in Migraine Disability Assessment (MIDAS)(Baseline to Weeks 4, 8, and 12)
- Change in Migraine Medication Use (medication type)(Run-in to Weeks 9-12)
研究者
研究点 (1)
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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 yearClick Therapeutics' CT-132 Digital Therapeutic Demonstrates Efficacy in Migraine Prevention- CT-132, a prescription digital therapeutic, significantly reduced monthly migraine days (MMDs) in a Phase 3 trial for episodic migraine prevention.
- The ReMMi-D study showed a statistically significant reduction of 0.9 MMDs relative to the sham control group over a 12-week period (p = 0.005).
- Patients treated with CT-132 experienced improvements in migraine-specific quality of life and reduced disability, with benefits observed as early as week 4.
- The digital therapeutic was well-tolerated, with no treatment-related adverse events reported, offering a potential new option for migraine management.2 years ago