Study of Two Digital Therapeutics for the Prevention of Episodic Migraine

(ReMMi-D Trial)

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

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)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

558 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two smartphone apps aimed at preventing migraines in teenagers and adults. The apps offer interactive tools and guidance to help reduce the frequency of migraine episodes.

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.

Research Team

Parth Shah

Principal Investigator

ObvioHealth

Eligibility Criteria

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

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

Is currently managing migraines with ≥1 prescription acute treatment and/or prescription first or second-line preventive medications, as assessed by a physician

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

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

Treatment Details

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.

Participant Groups

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+