Drugs have been the standard migraine treatment for decades. The severe headaches, nausea, and other problems associated with this common disorder now have a digital treatment option, a mobile app developed by prescription digital medicines developer Click Therapeutics.
The FDA marketing authorization announced Tuesday permits use of the Click digital therapeutic for the prevention of episodic migraine in patients age 18 and older. Episodic migraine is defined as having fewer than 15 headache days per month. The Click migraine app, known in development as CT-132, does not replace migraine drugs. The FDA authorization covers use of the app as an adjunct to standard migraine treatments, which is how it was evaluated in clinical trials.
Click’s research is based on mapping of the entire brain. The company has found faulty brain circuits implicated in many diseases, Chief Medical Officer Shaheen Lakan said in a 2023 interview. For various indications, the New York-based startup develops software that takes users through a series of tasks that have the effect of retraining and rewiring the brain over the course of weeks.
The FDA submission of CT-132 was based on two Phase 3 studies that compared Click’s migraine treatment to a sham mobile app for 12 weeks. Participants in the studies were already taking commonly prescribed migraine medications and they continued taking them during the clinical research. Results showed that CT-132 led to an average three-day reduction in monthly migraine days compared to the sham digital control. Participants who used the Click software also showed better scores measured by a quality-of-life questionnaire and a migraine disability assessment.
Patient engagement with the software was high. In the 12-week study, Click reported all study participants treated with CT-132 completed the 84 daily lessons. No device-related adverse effects were reported and no participants discontinued treatment. Results were initially reported last September and presented during the American Academy of Neurology annual meeting earlier this month.
“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,” Lakhan said in Click’s announcement of CLT-132’s FDA authorization.
The FDA reviewed CT-132 under its De Novo pathway for medical devices with low-to-moderate risk. As the first authorized device of its type, the Click app becomes the predicate device for future submissions of migraine mobile apps that will be reviewed under the agency’s 510(k) pathway.
CT-132 is the third product from Click’s internal research to pass regulatory muster with the FDA. The first was smoking-cessation app Clickotine. A little more than a year ago, the FDA cleared Rejoyn, a major depressive disorder digital therapeutic that Click developed in partnership with Otsuka Pharmaceutical. Click also has a presence in cardiometabolic disorders via its acquisition of AspyreRx and other assets of Better Therapeutics last year. In 2023, AspyreRx became the first FDA-authorized mobile app for type 2 diabetes.
Marketing authorization for CT-132 follows Click’s Series C financing announced in March, which the company said was funded entirely by France-based software company Dassault Systémes. The amount of the round was undisclosed, but an April 1 securities filing shows Click raised more than $48.5 million. With the financing, Medidata Solutions CEO Anthony Costello was elected to Click’s board of directors, the filing states. New York-based Medidata is a clinical trial technologies company that Dassault acquired in 2019 in a $5.8 billion deal.
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