CT-132 is an investigational prescription digital therapeutic intended for the preventive treatment of episodic migraine in adults 18 years of age and older for adjunctive use alongside other treatments for migraine.
CT-132 is an investigational device and is not currently available for sale in the United States. Its safety and effectiveness have not yet been evaluated by FDA.
How CT-132 Works
Brain hypersensitivity and enhanced pain signaling are key pathophysiological features of migraine.
The hypersensitive brain is more vulnerable to environmental and internal events, which can lead to debilitating migraine attacks and life disruptions.
CT-132 delivers a proprietary 12-week clinical intervention aimed at reducing brain hypersensitivity implicated in migraine by modulating patient responses to environmental and internal stimuli to help restore patients' ability to engage fully in daily activities.
Clinical Validation
The ReMMi-D pivotal trial is a fully decentralized, double-blind, randomized, and controlled clinical trial with 568 participants in the Intent-to-Treat (ITT) analysis set. The ReMMi-D trial evaluated the efficacy and safety of investigational prescription digital therapeutic CT-132 for the prevention of episodic migraine in patients 18 years and older, compared to a sham digital control intervention.
ReMMi-D enrolled patients on the most commonly prescribed acute and preventive migraine medications. The recently completed ReMMiD-C bridging study with 110 patients provided supportive information to the pivotal study in patients taking the new class of migraine-specific medications, CGRP inhibitors.
CT-132 alongside acute and preventive migraine medications
Reduction in monthly migraine days
Statistically significant reduction in monthly migraine days (MMDs) following 12 weeks of treatment compared to sham, (n=568, ITT population, -0.9 MMDs, p=0.005), with the treatment arm experiencing -3.04 MMDs by end of treatment.
Improvement in migraine-related disability
The treatment group experienced categorical improvement in the Migraine Disability Assessment (MIDAS) at the end of treatment (p=0.002).
Improvement in migraine-specific quality of life
Improved Migraine-Specific Quality-of-Life Questionnaire (MSQ) from as early as 4 weeks and through weeks 8 and 12 (p<0.001 at all time points).
Improvement in patient's impression of change
Patients reported improvement in their health due to CT-132 as measured by the Patient Global Impression - Change (PGI-C) at the end of the trial (p<0.001).
Prescription Drug Use Related Software Guidance
In September 2023, the FDA released a new guidance document titled Regulatory Considerations for Prescription Drug Use-Related Software (PDURS). This guidance indicates that manufacturers can now incorporate data demonstrating the added benefit of their software directly into the drug's package insert, providing a clear regulatory pathway for integrating software with existing drug products.
Both clinical studies were designed to evaluate the efficacy of adding the CT-132 prescription digital therapeutic on top of patients' existing migraine medication, and may provide data to inform added clinical benefit claims under the Prescription Drug Use-Related Software (PDURS) FDA Guidance.
Press Releases
Click Therapeutics Announces CT-132 Met Primary Endpoint for the Reduction of Monthly Migraine Days in ReMMi-D Pivotal Trial
Click Therapeutics Launches Additional Randomized Clinical Study in Migraine, Conducted in Partnership with Syneos Health
Click Therapeutics Initiates Fully Remote Pivotal Trial Using Investigational Prescription Digital Therapeutics to Treat Episodic Migraine
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Products in development are investigational Digital Therapeutics not for sale. FDA has not yet evaluated the safety or effectiveness of these products.