Objective:

Evaluate the safety and effectiveness of CT-132 in adults with episodic migraine (EM).

Background:

Migraine affects more than 40 million Americans and is the second-leading worldwide cause of disability. Despite advancements in pharmacotherapy, partial treatment response is common, driving an unmet need for additional reductions in monthly migraine days (MMDs). Prescription digital therapeutics (PDTs) can meet this need without adverse events or polypharmacy concerns common to pharmacotherapies. We report the results of Reduction in Monthly Migraine Days (ReMMi-D), a phase 3 trial of the investigational PDT CT-132 for the preventive treatment of EM in adults.

Design/Methods:

ReMMi-D was a 12-week, double-blind, randomized, controlled trial (RCT) assessing effectiveness and safety of CT-132 for preventive treatment of EM, adjunctive to acute and/or non–migraine-specific preventive medications. Participants aged ≥18 years with 4–14 MMDs during the run-in period were randomized to receive CT-132 or a sham digital therapeutic. The primary outcome was change in MMDs from the 4 weeks of run-in to the final 4 weeks of the intervention period. Additional outcomes included headache frequency, quality of life (QOL), disability, patient global impression of change, and safety. 

Results:

Of the 570 enrolled participants, 286 were randomized to CT-132 and 284 to sham. In the intent-to-treat population, after 12 weeks CT-132 significantly reduced MMDs compared to sham (least-squares mean [LSM] treatment difference, –0.90 MMDs, 95% CI, –1.53,–0.27, P=0.005) and monthly headache days (MHDs) (LSM treatment difference, –0.85 MHDs, 95% CI, –1.53,–0.16, P=0.015). Participants receiving CT-132 compared to those receiving sham reported statistically significant reductions in disability and improvements in QOL and migraine condition. No adverse events were related to treatment.

Conclusions:

Results from ReMMi-D establish CT-132 as a safe and effective first-in-class investigational PDT that delivers meaningful outcomes for adults with EM beyond those achieved with prescription medication alone.