MigraineReMMi-DNCT05853900

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

A study testing ReMMi-D Digital Therapeutic in people with Migraine and Episodic Migraine, run by Click Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized study of two digital therapeutics for the prevention of episodic migraine Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine, Episodic Migraine, Headache
What is being tested?: ReMMi-D Digital Therapeutic
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 568 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2023to 7 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Click Therapeutics
New York, New York, 10013

Other trials in United States

About this study

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

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

Read the detailed description

The purpose of this randomized ReMMi-D trial is to evaluate the effectiveness 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.

Conditions: Migraine, Episodic Migraine, Headache, Headache, Migraine
Being tested: ReMMi-D Digital Therapeutic
Keywords: Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app
Medical subject headings: Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReMMi-D Digital TherapeuticDevice
Evaluate the effectiveness 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.

Study groups in NCT05853900
Study group	Role	What they receive
Arm A	Experimental	Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. Receives: Device: ReMMi-D Digital Therapeutic
Arm B	Experimental	Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine. Receives: Device: ReMMi-D Digital Therapeutic

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in MMD (Monthly Migraine Days)
Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12).
Measured: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Secondary outcomes (8)

Participants Who Have at Least a 50% Reduction From Baseline
Participants who have at least a 50% reduction from baseline (28-day Run-in Period) in the number of MMDs to Week 12 (previous 28 days, Week 9 through Week 12)
Measured: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8
Change from baseline (28-day Run-in Period) in the number of MMDs recorded over the previous 28 days at Week 4 and at Week 8
Measured: Baseline (28-day Run-in Period) to Weeks 4 and 8
Change From Baseline in the Mean Number of MMD Over 12 Weeks
Change from baseline (28-day Run-in Period) in the mean number of MMDs over 12 weeks.
Measured: Baseline (28-day Run-in Period) to Week 12
Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12
Change in the number of headaches with at least moderate severity from baseline (28-day run-in period) to Week 12 (previous 28 days, Week 9 through Week 12).
Measured: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12 The MSQ is a self-administered, 14-item instrument that is completed at baseline, Week 4, Week 8, and Week 12. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.
Measured: Baseline (28-day Run-in Period) to Weeks 4, 8 and 12.
Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12)
Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12 The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self report 5-item questionnaire (scale: 0 - 90 for each of 5 subscales) designed to quantify headache-related disability over a 3-month period. The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability.
Measured: Baseline to Weeks 4, 8, and 12
Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication
Change in the number of migraines with use of an acute migraine medications from the run-in period to Weeks 9-12.
The number of migraines with use of an acute medication will be counted for the run-in period and for post randomization period. The change from baseline will be calculated as number of migraines in weeks 9-12 minus number of migraines in the run-in period with use of an acute medication.
Measured: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12
Change in the number of monthly headache days from baseline to Weeks 9-12
Measured: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 20237 May 2024

First posted11 May 2023
Study start28 Mar 2023
Primary completion7 May 2024
Study completion7 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05853900
Sponsor's protocol ID: CT-132-R-001
Acronym: ReMMi-D
Status last verified: Jul 2025
First submitted: 18 Apr 2023
Last updated: 3 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Lakhan SE, Petrova M, Snipes C, Kuka A, Peters-Strickland T, Besedina O, Taraboanta L, Livezey V, Speier A, Diamond M, Tepper SJ. Integrated analysis of two randomized controlled trials of a digital therapeutic for episodic migraine prevention. NPJ Digit Med. 2026 May 13;9(1):573. doi: 10.1038/s41746-026-02675-6.
PubMed 42129417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind, Parallel-Group, Virtual Study to Evaluate the Effectiveness and Safety of Two Digital Therapeutics in Late Adolescents and Adults for the Prevention of Episodic Migraine
ClinicalTrials.gov ID: NCT05853900
Acronym / sponsor ID: ReMMi-D / CT-132-R-001
Conditions: Migraine, Episodic Migraine, Headache, Headache, Migraine
Keywords: Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app
Study type: Interventional
Recruitment status: Completed
Enrolment: 568 participants (actual)
Lead sponsor: Click Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 28 Mar 2023 (actual)
Primary completion: 7 May 2024 (actual)
Study completion: 7 May 2024 (actual)
First posted: 11 May 2023 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Device: ReMMi-D Digital TherapeuticMobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.
Arm B	Experimental	Device: ReMMi-D Digital TherapeuticMobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (12 listed)

A participant will not be eligible for study entry if any of the following criteria are met:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ReMMi-D Digital TherapeuticEvaluate the effectiveness 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.	Device	Arm A, Arm B

Primary outcome

Change in MMD (Monthly Migraine Days)
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change in the number of MMDs from baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12).

8 secondary outcomes

Participants Who Have at Least a 50% Reduction From Baseline
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change From Baseline in the Number of MMD Recorded Over the Previous 28 Days at Week 4 and Week 8
Time frame: Baseline (28-day Run-in Period) to Weeks 4 and 8
Change From Baseline in the Mean Number of MMD Over 12 Weeks
Time frame: Baseline (28-day Run-in Period) to Week 12
Change in Number of Headaches With at Least Moderate Severity From Baseline to Week 12
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) Total Score Over the Previous 28 Days at Week 4, Week 8, and Week 12
Time frame: Baseline (28-day Run-in Period) to Weeks 4, 8 and 12.
Change From Baseline (28-day Run-in Period) in the Migraine Disability Assessment (MIDAS) to Week 12 (Previous 28 Days, Week 9 Through Week 12)
Time frame: Baseline to Weeks 4, 8, and 12
Change From Baseline (28-day Run-in Period) to Week 12 (Previous 28 Days, Week 9 Through Week 12) in the Number of Migraines With Use of an Acute Migraine Medication
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)
Change in the Number of Monthly Headache Days (MHDs) From Baseline to Week 12
Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A (CT-132)	285	255
Arm B (Digital Control)	283	262

Primary outcome: Change in MMD (Monthly Migraine Days)

Time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12). Least squares mean (95% Confidence Interval). Unit: migraine days per month

Measure	Arm A (CT-132) n = 266	Arm B (Digital Control) n = 264
Value	-3.04 (-3.49 to -2.58)	-2.14 (-2.59 to -1.69)

Population analysed: Intent-to-treat Population, all enrolled participants who were randomized, based on the assigned intervention in the randomization and recorded in the database.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (28-day run-in period) through Week 12 (up to 16 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	1 of 278 (0.4%)	22 of 278 (7.9%)	0 of 278
Arm B	0 of 278 (0%)	16 of 278 (5.8%)	0 of 278

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42129417Lakhan SE, Petrova M, Snipes C, Kuka A, Peters-Strickland T, Besedina O, Taraboanta L, Livezey V, Speier A, Diamond M, Tepper SJ. Integrated analysis of two randomized controlled trials of a digital therapeutic for episodic migraine prevention. NPJ Digit Med. 2026 May 13;9(1):573. doi: 10.1038/s41746-026-02675-6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parth Shah principal investigator

ObvioHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ReMMi-D Digital Therapeutic in people with Migraine and Episodic Migraine, run by Click Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MMD (Monthly Migraine Days) (time frame: Baseline (28-day Run-in Period) to Week 12 (previous 28 days, Week 9 through Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.