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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8 and 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Monthly Migraine Days (MMDs)

Secondary outcome measures

Change in Average Headache Severity

Change in MMDs at Weeks 4 and 8

Change in Mean MMDs

+6 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Click Therapeutics, Inc.Lead Sponsor

15 Previous Clinical Trials

2,857 Total Patients Enrolled

1 Trials studying Headache

558 Patients Enrolled for Headache

Shaheen LakhanStudy DirectorClick Therapeutics

3 Previous Clinical Trials

353 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined in this research endeavor?

"Affirmative. According to records on clinicaltrials.gov, this medical research project began recruitment on July 21st 2023 and was recently updated on August 15th 2023. The experiment is in need of 100 participants from 1 location."

Answered by AI

Are there still openings available for those wishing to take part in this experimental research?

"Affirmative. According to clinicaltrials.gov, this clinical trial was initially posted on July 21st 2023 and is still actively looking for participants as of August 15th 2023. The study requires the participation of 100 patients located at a single site."

Answered by AI

Is ReMMiD-C Therapeutic Arm A a safe and reliable option for individuals?

"We have rated ReMMiD-C Therapeutic Arm A's safety as a 3, considering there is ample evidence of its effectiveness and multiple studies that support its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004388.

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