Clinical trial NCT06004388: Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)
Official title: 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
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
CGRP
Calcitonin Gene-Related Peptide Inhibitor Therapy
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 110
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 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 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

* Is currently managing migraines with at least 1 prescription CGRP inhibitor therapy for the preventive or acute treatment of episodic or chronic migraine during the 3 months prior to screening.
* 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 specified eDiary and 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.
* Understands the use of and interest in the eDiary and the Study App during the screening period and the baseline visit (Day 1).

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.
* Participation in any other investigational clinical study

Primary outcomes:
measure: Change in Monthly Migraine Days (MMDs)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of Patients with Decrease in MMDs
timeFrame: Baseline to Week 12
measure: Change in MMDs at Weeks 4 and 8
timeFrame: Baseline to Weeks 4 and 8
measure: Change in Mean MMDs
timeFrame: Baseline to Week 12
measure: Change in Average Headache Severity
timeFrame: Run-in to Weeks 9-12
measure: Change in Migraine Questionnaire
timeFrame: Baseline to Weeks 4, 8 and 12
measure: Change in Migraine Disability Assessment (MIDAS)
timeFrame: Baseline to Weeks 4, 8, and 12
measure: Change in Migraine Medication Use (frequency)
timeFrame: Run-in to Weeks 9-12
measure: Change in Migraine Medication Use (dose)
timeFrame: Run-in to Weeks 9-12
measure: Change in Migraine Medication Use (medication type)
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: Click Therapeutics
name: Shaheen Lakhan
role: STUDY_DIRECTOR
References: