FDA clears its first prescription migraine app, from Click Therapeutics

Title

FDA Authorizes First Prescription Migraine Prevention App:
Click Therapeutics’ CT-132

Keywords

FDA clearance
Prescription digital therapeutic
Migraine prevention
Click Therapeutics
CT-132
Digital health
Mobile health app
Neurology
Behavioral therapy
Adjunctive migraine treatment

Key Facts

CT-132, developed by Click Therapeutics, is the first FDA-cleared prescription digital therapeutic (DTx) specifically for the prevention of episodic migraine in adults1 3 4.
The app delivers a 12-week, evidence-based behavioral therapy program via smartphone, targeting reduction of brain hypersensitivity linked to migraines1 2 4 6.
CT-132 is intended to be used alongside standard pharmacologic treatments, not as a standalone therapy. It complements current acute or preventive medications, including CGRP inhibitors1 2 4 5 6.
FDA clearance was granted through the De Novo pathway, reserved for novel medical devices and technologies1 4 5 6.
Approval was based on positive results from two randomized controlled trials (ReMMi-D and ReMMiD-C), demonstrating significant reduction in monthly migraine days, improved quality of life, and no device-related adverse events1 2 3 4 6 8.
In trials, CT-132 users reduced monthly migraine days by about three, roughly one more day than the sham digital control, with statistically significant results2 4 6 8.
High treatment adherence and engagement rates were reported, with nearly 100% median adherence to daily tasks in the pivotal study2 4 6.
CT-132 offers enhanced accessibility to migraine care, especially for patients with limited access to in-person behavioral therapy4 6.
This digital therapeutic marks a milestone in neurology for Click Therapeutics, which has prior FDA-cleared DTx products for psychiatry and cardiometabolic diseases1 6.
Migraine affects over 37 million adults in the U.S., with many still experiencing disabling symptoms despite medication3 4 6.
CT-132 exemplifies the growing role of software-based interventions in mainstream medical care, particularly for chronic neurological disorders1 4 6.