Integrated analysis of two randomized controlled trials of a digital therapeutic for episodic migraine prevention.

Migraine is a highly disabling neurological condition that requires effective preventive treatment options. We developed CT-132, a digital therapeutic that delivers clinically validated cognitive behavioral therapeutic interventions, as an adjunct to existing migraine therapies. We evaluated CT-132 for the preventive treatment of migraine in two randomized controlled trials, and this report is an integrated analysis of the two similarly designed trials: ReMMi-D (n = 568), which included patients on prescription migraine medications (not migraine-specific), and ReMMiD-C, a study (n = 110), in patients taking migraine-specific medications (i.e., CGRPi). Pooled data (N = 678) from these post-hoc analyses demonstrated that CT-132 significantly reduced monthly migraine days (LS mean difference, -0.86 days; p = 0.003) and improved secondary outcomes, had high engagement, and no device-related safety concerns. This data supports that CT-132 is an effective and safe digital therapeutic when used as an adjunct to medication for patients with episodic migraine. ReMMi-D: ClinicalTrials.gov NCT05853900 https://clinicaltrials.gov/study/NCT05853900?term=NCT05853900&rank=1 . REMMiD-C: ClinicalTrials.gov NCT06004388 https://clinicaltrials.gov/study/NCT06004388?term=NCT06004388&rank=1.