IOR-05 - Results From a Phase 3 Bridging Study of CT-132, an Investigational Prescription Digital Therapeutic, in Patients With Episodic Migraine Receiving Calcitonin Gene-Related Peptide Inhibitors
Senior Director, Scientific Innovations Click Therapeutics Inc New York City, NY, United States
CT-132 a prescription digital therapeutic indicated for the preventive treatment of episodic migraine in patients 18 years of age or older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. The indications for use for CT-132 are supported by the results from two randomized, double-blind digital-controlled clinical studies: the pivotal study (ReMMi-D) and the bridging study (ReMMiD-C). Here we report the results of the bridging study (ReMMiD-C) in which the effectiveness and safety of the adjunctive use of CT-132 alongside CGRPi medications was tested as compared to a sham digital control. This clinical study demonstrated that treatment with CT‑132 reduced monthly migraine days (MMDs) without any device-related adverse events.
Learning Objectives:
understand the role of prescription digital therapeutics in the preventive treatment of episodic migraine.
describe the evidence generation approach taken to establish, CT-132 (a prescription digital therapeutic indicated for the preventive treatment of episodic migraine indicated for adjunctive use alongside acute and / or other preventive treatments for migraine) as safe and effective.
articulate the results of a bridging study (ReMMiD-C) which demonstrated that treatment with CT‑132 reduced monthly migraine days (MMDs) without any device-related adverse events in the context of adjunctive use alongside CGRPi medications.
