Click Therapeutics, Inc. announced the launch of its second active randomized clinical trial in migraine, ReMMiD-C, Reduction in Monthly Migraine Days-CGRP study, a fully remote and decentralized trial designed to investigate the efficacy and safety of digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine currently receiving Calcitonin-Gene-Related Peptide (CGRP) inhibitor therapy. Click also recently launched the ReMMi-D study, a phase 3 pivotal registration study in approximately 558 patients, in March (NCT05853900). To execute this latest fully remote trial, Click has selected Syneos Health®.

Together, Click and Syneos Health are designing and deploying the study, enabling patients to consent, enroll, and receive treatment remotely. The combination of Click?s digital therapeutics delivered as mobile applications and Syneos Health Decentralized Solutions delivers innovative trial design expertise to accelerate patient access, enabling patients to participate in the trial anywhere, at any time, using their own devices. This modern approach reflects the real-world potential impact and accessibility of prescription digital therapeutics.

Click Therapeutics received Breakthrough Device Designation (BTDD) from FDA for its migraine program in December 2022. Migraine is a complex and debilitating condition that affects more than 40 million adults,1,2 and is the second leading cause of disability in the United States.3 Migraine is characterized by episodes of moderate-to-severe headache and generally associated with nausea and increased sensitivity to light and sound.4 Its burden is impacted by employment status, poverty, education attainment and insurance coverage. Although there are a variety of pharmacologic and nonpharmacologic acute and preventative treatments available, they are not without notable limitations, and patients often do not achieve full remission in response to pharmacotherapy alone.

A prescription digital therapeutic can help migraine patients access treatment, as well as give additional tools to providers treating migraine patients. The phase 3, randomized, double-blind trial will enroll approximately 100 patients in the United States. Trial intervention will be delivered over 12 weeks and efficacy will be evaluated between groups as a change from baseline in the number of monthly migraine days (MDDs).

The study will provide bridging data to evaluate the effectiveness of digital therapeutics for migraine in patients receiving CGRP inhibitor therapy, an emerging class of third line preventive medication for migraine such as Aimovig, Emgality, and Nurtec, as 50% of patients do not see the relief they expect from these interventions.5 This study will complement the clinical data from ReMMi-D in patients treated with first and second line preventive medications.