Digital Therapeutics for Migraine

(ReMMi-D Trial)

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Click Therapeutics, Inc.

Must be taking: Acute treatments, Preventive medications

Must not be taking: CGRP inhibitors, Opioids

Disqualifiers: Basilar migraine, Chronic pain, Psychiatric conditions, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test two new mobile apps designed to help prevent episodic migraines. Participants will use one of the two digital tools, including the ReMMi-D Digital Therapeutic, to evaluate their effectiveness in reducing migraine frequency. The trial suits individuals in the U.S. who have experienced migraines for at least a year and suffer from migraines 4-14 days a month. Participants should be comfortable using a smartphone and have regular internet access. As an unphased trial, it provides a unique opportunity to contribute to innovative migraine prevention research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently taking a prescription anti-calcitonin gene-related peptide (CGRP) for migraines.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ReMMi-D digital treatment underwent safety testing in earlier studies. These studies assessed the safety and effectiveness of two mobile apps for preventing occasional migraines. Trials with 558 participants found that the treatments were generally well-tolerated, with no reports of serious side effects. This suggests that both mobile apps used in the study are safe for use. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital therapeutics for episodic migraine prevention because they offer a novel, non-drug approach. Unlike traditional treatments like medications that often come with side effects, these mobile applications provide a software-based intervention, which could be easier and more accessible for late adolescents and adults. Arm A's application is designed specifically as a preventative tool, while Arm B's app is an investigational digital therapeutic, highlighting the potential for personalized, on-the-go migraine management. This innovative use of technology aims to empower users to manage their condition proactively and conveniently.

What evidence suggests that this trial's digital therapeutics could be effective for preventing episodic migraine?

This trial will compare two mobile applications, Arm A and Arm B, as software-based interventions for the preventive treatment of episodic migraine. Research has shown that the digital treatment CT-132, part of the ReMMi-D trial, helps prevent occasional migraines. Specifically, a study found that CT-132 significantly reduced the number of migraine days each month compared to a placebo after 12 weeks. Participants also reported improved quality of life related to migraines by weeks 8 and 12. The FDA approved this tool, confirming its effectiveness. These results suggest that CT-132 could be a promising option for those looking to manage their migraine episodes digitally. ^{1 2 3 5 6}

Who Is on the Research Team?

Parth Shah

Principal Investigator

ObvioHealth

Are You a Good Fit for This Trial?

This trial is for adults who've had migraines since before age 50, experience them 4-14 days a month, manage with prescription treatments, and have access to a smartphone. Excluded are those using certain painkillers frequently, with chronic pain conditions other than migraine or significant medical issues that could affect results.

Inclusion Criteria

Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form

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 owner of, and has regular access to, an email address

Exclusion Criteria

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

You have a history of basilar migraine or hemiplegic migraine.

You have ongoing chronic pain conditions like fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a run-in period to establish baseline migraine medication usage and headache severity

4 weeks

Treatment

Participants use the assigned digital therapeutic application for the prevention of episodic migraine

12 weeks

Virtual visits at Weeks 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ReMMi-D Digital Therapeutic

Trial Overview The study is examining two digital therapeutics designed to prevent episodic migraines. Participants will be randomly assigned to use one of the digital tools and their effectiveness in preventing migraines will be evaluated.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

Mobile application B is an investigational digital therapeutic that is being studied for the preventative treatment of episodic migraine.

Group II: Arm A Experimental Treatment 1 Intervention

Mobile application A as a software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults.

Who Is Running the Clinical Trial?

Click Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05853900

NCT05853900 | Study of Two Digital Therapeutics for the ... The purpose of this randomized ReMMi-D trial is to evaluate the effectiveness and safety of two prescription mobile applications that provide an interactive ...

2. clicktherapeutics.com clicktherapeutics.com/news/click-therapeutics-announces-ct-132-met-primary-endpoint-for-the-reduction-of-monthly-migraine-days-in-remmi-d-pivotal-trial

Stay up to date with news and updates The ReMMi-D trial evaluated the efficacy and safety of investigational prescription digital therapeutic CT-132 for the prevention of episodic migraine.

3. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000210426

Efficacy and Safety of a First-in-Class Investigational ... ReMMi-D was a 12-week, double-blind, randomized, controlled trial (RCT) assessing effectiveness and safety of CT-132 for preventive treatment of EM, adjunctive ...

4. clinicaladvisor.com clinicaladvisor.com/news/prescription-digital-therapeutic-cleared-for-migraine-prevention/

Prescription Digital Therapeutic Cleared for Migraine ... Findings from ReMMi-D showed CT-132 statistically significantly reduced MMDs compared with sham digital treatment after 12 weeks (treatment ...

5. neurologylive.com neurologylive.com/view/fda-approves-ct-132-as-first-digital-therapeutic-preventive-treatment-episodic-migraine

FDA Approves CT-132 as First Digital Therapeutic for ... In the study, CT-132 treatment resulted in significant improvements in Migraine-Specific Quality-of-Life (MSQ) scores by weeks 8 and 12 (P < .

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06004388/study-of-two-digital-therapeutics-for-the-prevention-of-episodic-migraine-receiving-cgrp-therapy-remmid-c

Study of Two Digital Therapeutics for the Prevention ... The purpose of this randomized trial is to evaluate the efficacy and safety of two prescription mobile applications that provide an interactive, ...