Pooled Trials Link CT-132 To Lower Monthly Migraine Days

Key Takeaways

• In pooled analyses, CT-132 was associated with fewer monthly migraine days in patients with episodic migraine using medication.
• One trial enrolled patients on prescription migraine medications that were not migraine-specific, while the other enrolled patients taking migraine-specific CGRP inhibitors.
• Investigators also reported improved secondary outcomes, high engagement, and no device-related safety concerns in the pooled analysis.

The integrated analysis of CT-132 linked this digital therapeutic, used alongside existing migraine medications for episodic migraine prevention, with fewer monthly migraine days. In pooled results, the least-squares mean difference was -0.86 days for the monthly migraine day endpoint (p=0.003). Investigators combined two randomized trials enrolling patients on different background medication regimens, allowing the pooled analysis to span distinct treatment settings. CT-132 was evaluated as a preventive option used with, rather than instead of, established migraine medications. Across the 2 trial populations assessed together, the integrated readout associated CT-132 with lower migraine frequency.

The post hoc assessment pooled data from the similarly designed randomized controlled trials ReMMi-D and ReMMiD-C. CT-132 was described as a digital therapeutic delivering clinically validated cognitive behavioral therapeutic interventions as an adjunct to existing migraine therapies. ReMMi-D enrolled 568 patients using prescription migraine medications that were not migraine-specific, while ReMMiD-C enrolled 110 patients taking migraine-specific medications described as CGRP inhibitors. Together, the pooled dataset included 678 patients and formed the integrated efficacy and safety readout.

Across the pooled dataset, researchers observed a significant reduction in monthly migraine days among participants assigned CT-132 alongside their ongoing medications. Investigators also reported improved secondary outcomes. Overall, the integrated analysis associated CT-132 with lower migraine frequency and improved secondary outcomes in episodic migraine.

High engagement with CT-132 was also reported across the integrated analysis. That finding accompanied the pooled efficacy results in the combined dataset.

Investigators also reported no device-related safety concerns in the pooled post hoc assessment of adjunctive use. The authors concluded that CT-132 was effective and safe when added to medication for episodic migraine. Throughout the pooled analysis, CT-132 was presented as an adjunct rather than a replacement for existing migraine therapies.