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

Click Therapeutics, Inc.1 site in 1 country110 target enrollmentJuly 21, 2023

ConditionsMigraine Episodic Migraine Headache Headache, Migraine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Migraine
Sponsor: Click Therapeutics, Inc.
Enrollment: 110
Locations: 1
Primary Endpoint: Change in Monthly Migraine Days (MMDs)
Status: Completed
Last Updated: last year

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 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.

Registry

clinicaltrials.gov

Start Date

July 21, 2023

End Date

June 5, 2024

Last Updated

last year

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 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

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.
•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.

Outcomes

Primary Outcomes

Change in Monthly Migraine Days (MMDs)

Time Frame: Baseline to Week 12

Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12

Secondary Outcomes

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)