A Randomized Double-blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Digital Therapeutics in Late Adolescents and Adults for the Prevention of Episodic Migraine

ClinicalTrials.gov processed this data on May 30, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified May 2024 by Click Therapeutics, Inc.

Sponsor

Click Therapeutics, Inc.

Information Provided by (Responsible Party)

Click Therapeutics, Inc.

Clinicaltrials.gov Identifier

NCT05853900
Other Study ID Numbers: CT-132-R-001
First Submitted: April 18, 2023
First Posted: May 11, 2023
Last Update Posted: May 31, 2024
Last Verified: May 2024
History of Changes

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Study Description

The purpose of this randomized ReMMi-D 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.
Condition or Disease Intervention/Treatment
  • Migraine
  • Episodic Migraine
  • Headache
  • Headache, Migraine
  • Device: ReMMi-D Digital Therapeutic

Study Design

Study TypeInterventional
Actual Enrollment558 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized Double-blind, Parallel-Group, Virtual Study to Evaluate the Efficacy and Safety of Two Digital Therapeutics in Late Adolescents and Adults for the Prevention of Episodic Migraine
Study Start DateMarch 28, 2023
Actual Primary Completion DateMay 17, 2024
Actual Study Completion DateMay 28, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Arm A
    • Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.
  • Device: ReMMi-D Digital Therapeutic
    • Evaluate the efficacy and safety of prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adults and adolescents.
  • Arm B
    • Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.
  • Device: ReMMi-D Digital Therapeutic
    • Evaluate the efficacy and safety of prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adults and adolescents.

Outcome Measures

Primary Outcome Measures

  1. Change in MMD (monthly migraine days) [Baseline to Week 12]
    Change from baseline in the number of Monthly Migraine Days (MMD) at Week 12 of intervention

Secondary Outcome Measures

  1. Proportion of Patients with Decrease in MMD [Baseline to Week 12]
    Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMD at Week 12
  2. Decrease in MMD [Baseline to Weeks 4 and 8]
    Change from baseline in the number of MMD recorded over the previous 28 days at Week 4 and Week 8
  3. Decrease in MMD [Baseline to Week 12]
    Change from baseline in the mean number of MMD over 12 weeks
  4. Change in average headache severity [Run-in to Weeks 9-12]
    Change in the average severity of headache from the run-in period to Weeks 9-12 assessed by Likert-type scale of 1-3 in severity
  5. Change in MSQ [Baseline to Weeks 4, 8 and 12]
    Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12
  6. Change in MIDAS [Baseline to Weeks 4, 8, and 12]
    Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12
  7. Change in frequency of Migraine Medications [Run-in to Weeks 9-12]
    Change in the frequency used of acute migraine medications from the run-in period to Weeks 9-12
  8. Change in dose of Migraine Medications [Run-in to Weeks 9-12]
    Change in the dose of acute migraine medications from the run-in period to Weeks 9-12
  9. Change in type of Migraine Medications [Run-in to Weeks 9-12]
    Change in the type of acute migraine medications from the run-in period to Weeks 9-12

Eligibility Criteria

Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
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
  • 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.
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.
  • 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.

Contacts and Locations

Sponsors and Collaborators Click Therapeutics, Inc.
Locations
  • Click Therapeutics | New York, New York, United States, 10013
Investigators
  • Principal Investigator: Parth Shah, ObvioHealth

More Information

Additional Relevant MeSH Terms

  • Migraine Disorders
  • Headache
  • Headache Disorders, Primary
  • Headache Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Pain
  • Neurologic Manifestations