Prescription digital therapeutic reduces monthly migraine days, phase 3 study shows

A novel digital therapeutic for migraine prevention met its primary endpoint of reducing the number of monthly migraine days, according to results from a phase 3 clinical trial.

Device manufacturer Click Therapeutics said in a press release that a randomized, double-blind, sham-controlled study of CT-132, which is intended to be used in conjunction with other migraine treatments, resulted in a statistically significant reduction in monthly migraine days (MMDs) after 12 weeks of treatment compared with sham. The treatment arm experienced 3.04 fewer MMDs by end of the 12 weeks.

Further data cited in the release showed that CT-132 also improved scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) as early as 4 weeks, then again through weeks 8 and 12, while also improving scores on the Migraine Disability Assessment by treatment conclusion.

Participants additionally reported a benefit to their overall health, as measured by the Patient Global Impression – Change, at the end of the trial. CT-132 was well-tolerated with no record of treatment-related adverse events, per the release.

“This is a significant milestone for more than 1 billion people worldwide living with migraine," Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, said in the release. “We look forward to advancing our FDA breakthrough designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”