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COMPLETEDPHASE3

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

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

NCT06004388•Click Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+6 more criteria

Exclusion Criteria

•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.
•Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine indication.
•Participation in any other investigational clinical study

Locations (1)

Click Therapeutics

New York, New York, United States

Key Dates

Start Date

July 21, 2023

Primary Completion Date

May 21, 2024

Completion Date

June 5, 2024

Last Updated

December 18, 2024

Enrollment

110

ACTUAL participants

Conditions

MigraineEpisodic MigraineHeadacheHeadache, Migraine

Interventions

Click Digital Therapeutic

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

MyVitalC: Sleep and Everyday Headache Management

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine