Revolutionizing Migraine Management: FDA Approves First Digital Therapeutic
In a groundbreaking development for migraine sufferers, the U.S. FDA has granted marketing authorization for **CT-132**, marking the emergence of the first prescription digital therapeutic (PDT) designed specifically for the **preventive treatment of episodic migraine** in adults. Developed by Click Therapeutics, this innovative smartphone-based application received its approval through the De Novo pathway for first-in-class medical devices on April 15, 2025.1
Transforming Migraine Treatment
**CT-132** is intended for use alongside conventional acute and preventive migraine treatments for patients aged **18 and older**. This clinical advancement is grounded in extensive research, supported by **two randomized controlled trials** demonstrating the efficacy of the digital therapeutic in conjunction with standard migraine pharmacotherapy.1
Dr. Shaheen Lakhan, Chief Medical and Scientific Officer at Click Therapeutics, emphasizes the significance of this achievement: “This marks a significant milestone for the more than **37 million adults** in the U.S. who live with migraine. As a groundbreaking digital therapeutic for migraine prevention, **CT-132** offers eligible patients a new path to reducing the burden caused by migraine, accessible through an **evidence-based mobile application** on their smartphone.”1
Pivotal Trials: Evaluating Efficacy
The pivotal phase 3 **ReMMi-D** trial (NCT05853900) included **558 individuals** suffering from migraines who received standard care. Results were striking: CT-132 met its primary endpoint, revealing a **statistically significant reduction** in monthly migraine days (MMDs) after **12 weeks**, showing a treatment difference of -0.9 MMDs when compared to a sham digital control (P = 0.005). By the study’s conclusion, participants in the treatment arm experienced a remarkable mean reduction of **-3.04 MMDs**.2
In tandem, a follow-up study, **ReMMiD-C** (NCT06004388), confirmed similar results specifically among those taking a CGRP inhibitor. This novel approach uniquely allowed patients to maintain their existing medication regimens, enabling the evaluation of the **additive effects** of the digital therapeutic without requiring washout periods.
Secondary outcomes from the ReMMi-D trial illustrated **improvements in migraine-related quality of life**, noted as early as **4 weeks** into treatment. These enhancements were assessed through the **Migraine-Specific Quality-of-Life Questionnaire (MSQ)**, reinforcing the positive impact of CT-132 with significant findings (P < 0.001) at both 8 and 12 weeks.
Importantly, adherence to CT-132 was exceptionally high throughout the 12-week treatment, with participants completing a median of **84 out of 84 daily lessons**, signaling strong engagement with the therapeutic regimen. No discontinuations were reported due to treatment-related adverse events, showcasing the product’s **safety profile**.
A Complementary Approach
With no contraindications, CT-132 stands out as a **complementary intervention** to existing migraine treatments. This powerful device integrates evidence-based behavioral therapies with proprietary action mechanisms through an easy-to-use smartphone application.
Dr. Stewart J. Tepper, Vice President of the New England Institute for Neurology and Headache, expressed enthusiasm for this innovation: “As a clinician, I find this particularly exciting because there’s currently nothing like this in our **migraine treatment arsenal**. While behavioral techniques are known to provide additional benefits, access remains a challenge across many parts of the country.”
Looking ahead, Click Therapeutics envisions further development of CT-132 as a **”software-enhanced drug™ therapy”**, aligning with the FDA’s evolving guidance on Prescription Drug Use-Related Software (PDURS).
References
1. 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. News release. Click Therapeutics. April 15, 2025. Accessed April 16, 2025. [Read more here](https://www.clicktherapeutics.com/news/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).
2. Click Therapeutics announces CT-132 met primary endpoint for the reduction of monthly migraine days in ReMMi-D pivotal trial. News release. Click Therapeutics. September 4, 2024. Accessed April 16, 2025. [Discover the study results](https://www.businesswire.com/news/home/20240904512812/en/Click-Therapeutics-Announces-CT-132-Met-Primary-Endpoint-for-the-Reduction-of-Monthly-Migraine-Days-in-ReMMi-D-Pivotal-Trial).
