Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

Migraine Clinical Trial

— ReMMi-D  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05853900
• Other study ID #: CT-132-R-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 28, 2023
• Est. completion date: May 28, 2024

Study information

• Verified date: March 2024
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 558
• Est. completion date: May 28, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Headache
• Headache, Migraine
• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MMD (monthly migraine days)	Change from baseline in the number of Monthly Migraine Days (MMD) at Week 12 of intervention	Baseline to Week 12
Secondary	Proportion of Patients with Decrease in MMD	Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMD at Week 12	Baseline to Week 12
Secondary	Decrease in MMD	Change from baseline in the number of MMD recorded over the previous 28 days at Week 4 and Week 8	Baseline to Weeks 4 and 8
Secondary	Decrease in MMD	Change from baseline in the mean number of MMD over 12 weeks	Baseline to Week 12
Secondary	Change in average headache severity	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	Run-in to Weeks 9-12
Secondary	Change in MSQ	Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12	Baseline to Weeks 4, 8 and 12
Secondary	Change in MIDAS	Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12	Baseline to Weeks 4, 8, and 12
Secondary	Change in frequency of Migraine Medications	Change in the frequency used of acute migraine medications from the run-in period to Weeks 9-12	Run-in to Weeks 9-12
Secondary	Change in dose of Migraine Medications	Change in the dose of acute migraine medications from the run-in period to Weeks 9-12	Run-in to Weeks 9-12
Secondary	Change in type of Migraine Medications	Change in the type of acute migraine medications from the run-in period to Weeks 9-12	Run-in to Weeks 9-12