CT-132 is the first FDA-authorized prescription digital therapeutic for episodic migraine prevention, shown to reduce monthly migraine days when used with standard treatment through a smartphone-based platform.

The FDA has granted De Novo marketing authorization to Click Therapeutics for CT-132, the first prescription digital therapeutic (PDT) approved in the U.S. for the preventive treatment of episodic migraine. Designed for adjunctive use alongside acute and/or preventive pharmacologic treatments, CT-132 is a mobile application that delivers evidence-based behavioral therapy to adult patients via smartphone.

The authorization is supported by data from the ReMMi-D pivotal randomized controlled trial (NCT05853900) and the ReMMiD-C bridging study (NCT06004388). In ReMMi-D (n=568), CT-132 reduced monthly migraine days (MMDs) at 12 weeks compared with a sham digital control. Participants receiving CT-132 had an average decrease of 3.04 MMDs over the 12-week treatment period. Improvements in quality of life and migraine-related disability were observed, as measured by the Migraine-Specific Quality-of-Life Questionnaire and the Migraine Disability Assessment, respectively. No device-related adverse events or treatment-emergent adverse event–related discontinuations were reported. Adherence to the intervention was high, with participants completing a median of 84 out of 84 daily lessons.

The ReMMiD-C study (n=110) evaluated CT-132 in patients using calcitonin gene-related peptide inhibitors and demonstrated comparable performance, though it did not include formal hypothesis testing. In both studies, patients continued their existing pharmacotherapy, enabling assessment of CT-132’s additive benefit without a washout period.

CT-132 is intended to complement existing treatment regimens rather than replace them. There are no contraindications to its use. The product may also support future clinical benefit claims aligned with the FDA’s draft guidance on Prescription Drug Use-Related Software.

This is the third FDA-authorized product from Click Therapeutics, following Rejoyn for major depressive disorder and AspyreRx for type 2 diabetes. CT-132 represents the company’s first approval in neurology and the first PDT to receive marketing authorization for a pain-related indication.

Reference:

Click Therapeutics. Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States [press release].