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

Click Therapeutics, Inc.1 site in 1 country568 target enrollmentMarch 28, 2023

ConditionsMigraine Episodic Migraine Headache Headache, Migraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Migraine
Sponsor: Click Therapeutics, Inc.
Enrollment: 568
Locations: 1
Primary Endpoint: Change in MMD (Monthly Migraine Days)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

Brief Summary

Randomized study of two digital therapeutics for the prevention of episodic migraine

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

March 28, 2023

End Date

May 7, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Click Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Change in MMD (Monthly Migraine Days)

Time Frame: 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).

Secondary Outcomes

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))