Clinical trial NCT05853900: Study of Two Digital Therapeutics for the Prevention of Episodic Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Episodic Migraine
Headache
Headache, Migraine
Keywords: Prescription digital therapeutic (PDT)
Software as a Medical Device (SaMD)
Smartphone app
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* A participant will be eligible for entry into the study if all of the following criteria are met:

  1. Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
  2. Lives in the United States.
  3. Adult or late adolescent, 18 years of age or older at the time of informed consent.
  4. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
  5. 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.

     1. Age of onset of migraines prior to 50 years of age
     2. Migraine attacks, on average, lasting 4-72 hours if untreated
     3. 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)
     4. Four to fourteen migraine days during the run-in period
  6. Is currently managing migraines with ≥1 prescription acute treatment and/or prescription first or second-line preventive medications, as assessed by a physician.
  7. 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.
  8. Is willing and able to receive SMS text messages and push messages on their smartphone.
  9. Is the owner of, and has regular access to, an email address.
  10. 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:

  1. History of basilar migraine or hemiplegic migraine.
  2. Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS).
  3. 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.
  4. 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.
  5. 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.
  6. Currently taking a prescription anti-calcitonin gene-related peptide (CGRP) for either episodic or chronic migraine.
  7. Post-traumatic headache, persistent post-traumatic headache, or post-concussion syndrome.
  8. 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.
  9. 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.
  10. Previous enrollment in any digital therapeutics pilot or pivotal study for a migraine indication.
  11. Participation in any other investigational clinical study while participating in this clinical study.

Primary outcomes:
measure: Change in MMD (monthly migraine days)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of Patients with Decrease in MMD
timeFrame: Baseline to Week 12
measure: Decrease in MMD
timeFrame: Baseline to Weeks 4 and 8
measure: Decrease in MMD
timeFrame: Baseline to Week 12
measure: Change in average headache severity
timeFrame: Run-in to Weeks 9-12
measure: Change in MSQ
timeFrame: Baseline to Weeks 4, 8 and 12
measure: Change in MIDAS
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in frequency of Migraine Medications
timeFrame: Run-in to Weeks 9-12
measure: Change in dose of Migraine Medications
timeFrame: Run-in to Weeks 9-12
measure: Change in type of Migraine Medications
timeFrame: Run-in to Weeks 9-12
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: ObvioHealth
name: Parth Shah
role: PRINCIPAL_INVESTIGATOR
References: