What is the mechanism of action of this treatment?

Common treatments for migraine work through various mechanisms. Pharmacological treatments like triptans target serotonin receptors to constrict blood vessels and block pain pathways, while non-pharmacological treatments such as behavioral and cognitive interventions aim to modify pain perception and reduce stress. Techniques like biofeedback, cognitive-behavioral therapy (CBT), and relaxation training are used to manage triggers and symptoms. Understanding these mechanisms helps patients select effective treatments tailored to their needs, potentially reducing the frequency and severity of migraine attacks.

What side effects are associated with this type of intervention?

Behavioral and cognitive interventions for migraine, such as cognitive-behavioral therapy (CBT), biofeedback, and relaxation training, are generally well-tolerated with minimal side effects. The most commonly reported issues are mild and may include temporary discomfort or anxiety during initial sessions, which typically resolve as the patient becomes accustomed to the therapy. These treatments focus on reducing headache symptoms and improving coping mechanisms, making them a favorable option for patients seeking non-pharmacologic approaches.

What prior FDA approvals exist?

The FDA has approved various treatments for migraine, including pharmacological options like triptans (e.g., sumatriptan) and newer CGRP inhibitors. For non-pharmacological treatments, the FDA has permitted the marketing of digital therapeutics, such as game-based interventions for ADHD, which may have parallels in migraine treatment through behavioral and cognitive interventions. Additionally, neuromodulation devices like transcutaneous electrical nerve stimulation and transcranial magnetic stimulation have been approved for migraine management, reflecting a trend towards integrating non-drug therapies in clinical practice.

What other types of research exist?

Promising novel alternatives to digital therapeutics for migraine patients in 2024 include: 1) Lasmiditan, a serotonin receptor agonist approved for acute migraine treatment. 2) Remote Electrical Neuromodulation (REN), which has shown efficacy in relieving acute migraine pain. 3) Single-pulse Transcranial Magnetic Stimulation (TMS), approved for both acute treatment and prevention of migraine. 4) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated effectiveness in acute migraine therapy. These options provide diverse mechanisms of action and can be considered based on individual patient needs and preferences.

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Digital Therapeutic

Arm A for Migraine (ReMMi-D Trial)

Phase 3

Waitlist Available

Led By Parth Shah

Research Sponsored by Click Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8 and 12

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves digital therapeutics rather than medication, traditional side effects like you might see with drugs aren't expected. However, users may experience discomfort or frustration if they find the technology difficult to use.

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 MMD (monthly migraine days)

Secondary study objectives

Change in MIDAS

Change in MSQ

Change in average headache severity

+5 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 Intervention

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

Group II: Arm AExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ReMMi-D Digital Therapeutic

2023

Completed Phase 3

~560

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraine work through various mechanisms. Pharmacological treatments like triptans target serotonin receptors to constrict blood vessels and block pain pathways, while non-pharmacological treatments such as behavioral and cognitive interventions aim to modify pain perception and reduce stress. Techniques like biofeedback, cognitive-behavioral therapy (CBT), and relaxation training are used to manage triggers and symptoms. Understanding these mechanisms helps patients select effective treatments tailored to their needs, potentially reducing the frequency and severity of migraine attacks.

Unveiling the comparative efficacy and tolerability of comprehensive treatments for migraine: A protocol of systematic review and Bayesian network meta-analysis.How to Apply the AHS Evidence Assessment of the Acute Treatment of Migraine in Adults to your Patient with Migraine.Pharmacological trials in migraine: it's time to reappraise where the headache is and what the pain is like.