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Digital Therapy for Migraine Prevention

Phase 3

Waitlist Available

Research Sponsored by Click Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult or late adolescent, ≥ 18 years of age at the time of informed consent

Has at least a 1-year history of migraine consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD), 3rd Edition

Must not have

History of basilar migraine or hemiplegic migraine

Active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8 and 12

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests if two digital therapies can help prevent migraine in people already taking CGRP inhibitor drugs.

Who is the study for?

This trial is for adults in the US with a history of migraines, who are currently using CGRP inhibitor therapy. Participants must have an iPhone (iOS 14+) or Android (OS 11+), access to email and internet, and be willing to use study apps. Excluded are those with certain migraine types, chronic pain syndromes, other significant neurological disorders, recent substance abuse, or high usage of analgesics.

What is being tested?

The study compares two digital therapeutics designed to prevent episodic migraines in patients already on CGRP inhibitors. It's randomized: participants will be assigned by chance to one of the digital treatments without choosing which one they receive.

What are the potential side effects?

Since this trial involves digital therapeutics rather than medication, traditional side effects like nausea or headache aren't expected. However, users may experience eye strain or headaches from screen time or stress if technical issues arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with migraines for at least 1 year.

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I have been using a prescription CGRP inhibitor for migraines in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of severe migraines with specific symptoms.

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I have a long-term pain condition like fibromyalgia or CRPS.

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I do not have any major psychiatric or neurological conditions that could affect study results.

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I suffer from headaches after a head injury.

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I completed all required eDiary inputs and onboarding activities during the run-in period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 4, 8 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 4, 8 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Monthly Migraine Days (MMDs)

Secondary study objectives

Change in Average Headache Severity

Change in MMDs at Weeks 4 and 8

Change in Mean MMDs

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ReMMiD-C Therapeutic Arm BExperimental Treatment1 Intervention

Mobile 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.

Group II: ReMMiD-C Therapeutic Arm AExperimental Treatment1 Intervention

Mobile 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.

0 / 8Eligibility criteria met