Click Therapeutics has announced positive results from its Phase 3 ReMMi-D trial, demonstrating that its investigational prescription digital therapeutic, CT-132, significantly reduces monthly migraine days (MMDs) in adults with episodic migraine. The decentralized, double-blind study, which included 568 participants, compared CT-132 to a sham digital control intervention over a 12-week treatment period.
The study's primary endpoint was met, with CT-132 demonstrating a statistically significant reduction in MMDs relative to the sham control (–0.9 MMDs; P = .005). Patients in the active treatment group experienced an average reduction of 3.04 MMDs by the end of the 12-week period. These findings suggest a clinically meaningful benefit for individuals seeking preventive migraine treatment.
Improvements in Quality of Life and Disability
Beyond the primary endpoint, the ReMMi-D trial also assessed the impact of CT-132 on patients' quality of life and disability. Results indicated significant improvements in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores at weeks 8 and 12 (both P <.001 at all time points), with improvements observed as early as week 4. Furthermore, categorical enhancements were seen in the Migraine Disability Assessment (MIDAS) scores among CT-132-treated patients at the conclusion of the treatment period.
Safety and Tolerability
An important aspect of any new therapy is its safety profile. In the ReMMi-D trial, CT-132 was found to be safe and well-tolerated, with no treatment-related adverse events reported. This is a crucial factor for a condition like migraine, where patients may be hesitant to add new medications to their regimen due to potential side effects.
Supporting Data and Future Directions
Click Therapeutics also highlighted supportive data from its Phase 3 bridging study, ReMMiD-C (NCT06004388), which included 110 patients with migraine already receiving CGRP inhibitor therapy. This randomized, double-blind, 12-week trial complemented the ReMMi-D data, providing a more comprehensive understanding of CT-132's efficacy across different patient populations.
"This is a significant milestone for more than one billion people worldwide living with migraine," said Shaheen Lakhan, MD, PhD, FAAN, chief medical officer at Click Therapeutics. "We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care."
Implications for Migraine Treatment
The positive results from the ReMMi-D trial suggest that CT-132 could offer a valuable new approach to migraine prevention. Unlike traditional pharmaceutical interventions, CT-132 is a digital therapeutic, delivered via smartphone, which may improve access to care and patient adherence. The therapy is designed to reduce brain hypersensitivity implicated in migraine by modulating patient responses to environmental and internal stimuli, potentially restoring patients’ ability to engage fully in daily activities.
According to Stewart Tepper, MD, vice president of the New England Institute for Neurology and Headache, "The clinical data demonstrate a successful reduction in monthly migraine days, which was the primary endpoint, as well as improving quality of life and reducing disability. This is the first migraine digital therapeutic to be studied with this degree of rigor, and the availability of CT-132 would be a very useful addition to our migraine armamentarium providing additional benefit to patients on migraine medication and expanding access to non-pharmacological treatment options."
