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FDA Approves CT-132 as First Digital Therapeutic for Preventive Treatment of Episodic Migraine
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Key Takeaways
- CT-132 is the first FDA-approved digital therapeutic for episodic migraine prevention, intended for use alongside existing treatments.
- Approval was based on two randomized trials showing significant reductions in monthly migraine days and quality-of-life improvements.
CT-132, an approach that aims to reduce brain hypersensitivity, becomes the first marketed digital treatment to prevent migraine, intended to be used with other previously approved medications.
Shaheen Lakhan, MD, PhD, FAAN
According to a new announcement, the FDA has made a major decision, approving Click Therapeutics’ CT-132 as the first prescription digital therapeutic for the preventive treatment of episodic migraine in adults. Approved through the De Novo pathway, the therapy is indicated for patients aged 18 years and older, intended for adjunctive use alongside acute and/or other preventive treatments for migraine.1
The medication’s approval was primarily based on data from 2, double-blind, decentralized randomized trials: the phase 3 ReMMi-D trial (NCT05853900) and the ReMMiD-C bridging study (NCT06004388). In its label, CT-132 carries no contraindications, and is not intended to be used as a standalone therapy. CT-132 does not replace or substitute other migraine treatments, and patients who opt for this digital therapeutic should continue their current treatment as directed.
"This marks a significant milestone for the more than 37 million adults in the US who live with migraine," Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer at Click, said in a statement.1 "As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients."
CT-132 operates by delivering a 12-week, app-based intervention that integrates multiple evidence-based behavioral techniques, including elements of cognitive behavioral therapy. The therapeutic aims to modulate dysfunctional neurocircuitry associated with migraine–specifically by targeting sensory, autonomic, and affective networks. By strengthening neurolimbic circuitry, CT-132 seeks to reduce the brain’s hypersensitivity to internal and external stimuli, thereby decreasing the frequency of migraine attacks.
ReMMi-D, a 568-patient study of adults with migraine, met its primary end point, with results revealing a significant reduction in monthly migraine days (MMDs) among patients treated with CT-132 over a 12-week period. After 12 weeks of treatment, investigators observed a statistically significant attenuation in the number of MMDs relative to those on sham (–0.9 MMDs; P = .005), with those on active treatment experiencing –3.04 MMDs by end of the study period.2
In the study, CT-132 treatment resulted in significant improvements in Migraine-Specific Quality-of-Life (MSQ) scores by weeks 8 and 12 (P < .001 at both time points), with noticeable gains emerging as early as week 4. By the end of the treatment period, patients receiving CT-132 also demonstrated categorical improvements on the Migraine Disability Assessment (MIDAS) questionnaire.
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"With this landmark, first-in-class FDA authorization in episodic migraine, Click’s interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology," David Benshoof Klein, chief executive officer at Click, said in a statement.1 "As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click’s platform to deliver meaningful outcomes across therapeutic areas."
The ReMMi-D trial enrolled patients with at least a 1-year history of migraine, confirmed by ICHD-3 criteria, who were using at least one prescription acute or preventive treatment. Individuals on anti-CGRP therapies were excluded. Both the CT-132 and sham groups showed nearly 100% median adherence to daily tasks, and patients receiving CT-132 reported significant health improvements by week 12, as measured by Patient Global Impression-Change (P < .001). The therapy was also well tolerated, with no treatment-related adverse events observed.
ReMMiD-C, another fully remote and decentralized trial, provided supportive information to the pivotal ReMMi-D study. This randomized, double-blind, 12-week study involving 110 patients who were receiving calcitonin gene-related peptide (CGRP) therapy, was used to complement clinical data from ReMMi-D in patients treated with first and second line preventive medications. While ReMMi-C also evaluated CT-132 vs a sham digital control, the study was without formal hypothesis testing.
