CompletedNot Applicable

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

United States568 participantsStarted 2023-03-28

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.

Change in MMD (Monthly Migraine Days)

Timeframe: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

NCT IDNCT05853900

SponsorClick Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-07

Results submitted2025-05-12

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.