In a major step forward for digital health, the U.S. Food and Drug Administration (FDA) has officially approved CT-132 from Click Therapeutics — the first prescription digital therapeutic (PDT) for the preventive treatment of episodic migraine in adults.
This new therapy is not a pill or an injection. Instead, it’s a smartphone-based application that offers migraine patients a new, non-invasive way to manage and reduce the frequency of migraine attacks.
CT-132 is a 12-week digital program designed to complement existing acute and preventive migraine treatments. It uses scientifically backed Cognitive Behavioral Therapy (CBT) techniques to retrain the brain’s response to environmental and internal triggers.
By modulating neural circuits linked to migraines, CT-132 aims to reduce brain hypersensitivity — ultimately cutting down the number of migraine days each month.
1.The ReMMi-D Trial
- Included 558 patients already on migraine medications.
- Participants using CT-132 had a significant reduction in monthly migraine days compared to those using a placebo app.
- Improvements were also seen in quality of life and reduction in migraine-related disability.
2. The ReMMiD-C Bridging Study
- Focused on patients receiving CGRP inhibitors (a newer class of migraine drugs).
- CT-132 was found to be equally effective when used alongside these therapies.
Migraines affect over 37 million adults in the United States alone, severely impacting daily life. Traditional preventive treatments, such as daily medications or monthly injections, are not always effective — and often come with side effects.
CT-132 offers:
- A non-pharmacological option
- Easy access through a smartphone
- A personalized behavioral therapy approach
- No systemic side effects
This approval is not just a win for migraine patients — it’s a milestone for digital therapeutics as a whole.
CT-132 paves the way for the broader adoption of app-based therapies across many areas of medicine. As more digital therapeutics emerge, patients and healthcare providers alike will have new tools to manage chronic conditions more effectively and conveniently.
