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MigrainePhase 3NCT06004388

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

A Phase 3 study testing Click 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 in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy 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?
Click Digital Therapeutic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
21 Jul 2023to 5 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 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:
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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 or more 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 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).

Who cannot join

  • 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.
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  • 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

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 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

Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy

Read the 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.

Being tested
Click Digital Therapeutic
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, CGRP, Calcitonin Gene-Related Peptide Inhibitor Therapy
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.

  • Click Digital TherapeuticDevice

    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 receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy

Study groups in NCT06004388
Study groupRoleWhat they receive
ReMMiD-C Therapeutic Arm AExperimentalMobile application A (ReMMiD-C Digital Therapeutic) as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
Receives: Device: Click Digital Therapeutic
ReMMiD-C Therapeutic Arm BExperimentalMobile application B as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy.
Receives: Device: Click Digital Therapeutic

What is being measured

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

  1. Change in Monthly Migraine Days (MMDs)

    Change from baseline in the number of Monthly Migraine Days (MMDs) at Week 12

    Measured: Baseline to Week 12

Secondary outcomes (9)

  1. Proportion of Patients with Decrease in MMDs

    Proportion of participants who have at least a 50% reduction from baseline in the mean number of MMDs at Week 12

    Measured: Baseline to Week 12

  2. Change in MMDs at Weeks 4 and 8

    Change from baseline in the number of MMDs recorded over the previous 28 days at Week 4 and Week 8

    Measured: Baseline to Weeks 4 and 8

  3. Change in Mean MMDs

    Reduction from baseline in the mean number of MMDs over 12 weeks

    Measured: Baseline to Week 12

  4. Change in Average Headache Severity

    Change in the average severity of headache from the run-in period to Weeks 9-12

    Measured: Run-in to Weeks 9-12

  5. Change in Migraine Questionnaire

    Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQ) at Week 4, Week 8, and Week 12

    Measured: Baseline to Weeks 4, 8 and 12

  6. Change in Migraine Disability Assessment (MIDAS)

    Change from baseline in the Migraine Disability Assessment (MIDAS) at Week 4, Week 8, and Week 12

    Measured: Baseline to Weeks 4, 8, and 12

  7. Change in Migraine Medication Use (frequency)

    Change in the use (frequency) of acute migraine medications from the run-in period to Weeks 9-12

    Measured: Run-in to Weeks 9-12

  8. Change in Migraine Medication Use (dose)

    Change in the use (dose) of acute migraine medications from the run-in period to Weeks 9-12

    Measured: Run-in to Weeks 9-12

  9. Change in Migraine Medication Use (medication type)

    Change in the use (type) of acute migraine medications from the run-in period to Weeks 9-12

    Measured: Run-in to Weeks 9-12

Timeline

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

  1. First posted22 Aug 2023
  2. Study start21 Jul 2023
  3. Primary completion21 May 2024
  4. Study completion5 Jun 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004388
Sponsor's protocol ID
CT-132-R-002
Status last verified
Mar 2024
First submitted
26 Jul 2023
Last updated
18 Dec 2024
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Click 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 16 inclusion and 11 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 18 Dec 2024. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Monthly Migraine Days (MMDs) (time frame: Baseline to 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 NCT06004388, 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 18 Dec 2024.

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