CT-132 Meets Primary Endpoint for Reducing Monthly Migraine Days in Pivotal Trial

Click Therapeutics, Inc., a pioneer in Digital Therapeutics™, has announced the successful results of their randomized, double-blind, controlled, decentralized study of CT-132, aimed at preventing migraines. The study, titled ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900), demonstrated that CT-132 significantly reduces the number of monthly migraine days (MMDs) after 12 weeks of treatment compared to a sham treatment.

The study involved 568 participants and showed that those using CT-132 experienced a reduction of 3.04 MMDs by the end of the treatment period. This figure is statistically significant when compared to the sham group, which saw a reduction of only 0.9 MMDs. Furthermore, the treatment also improved scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) and the Migraine Disability Assessment (MIDAS), showing positive results as early as four weeks into the treatment.

Patient-reported outcomes also indicated significant improvements in their overall health as measured by the Patient Global Impression - Change (PGI-C) metric. High levels of engagement and adherence to the treatment protocol were maintained throughout the 12-week period, with both the intervention and sham groups completing nearly all daily tasks. Importantly, CT-132 was well tolerated, with no treatment-related adverse events reported.

The study's findings were further supported by data from the recently completed ReMMiD-C bridging study (NCT06004388), which focused on patients taking new classes of migraine-specific medications, specifically CGRP inhibitors. This supplementary study provided additional insights that reinforced the positive outcomes of the pivotal research.

Dr. Shaheen Lakhan, Chief Medical Officer at Click Therapeutics, stated that this development is a significant milestone for the over one billion individuals worldwide who suffer from migraines. He emphasized that CT-132 is the first digital therapeutic for migraines to be rigorously tested in clinical trials, with promising results in reducing monthly migraine days and improving patients' quality of life.

Dr. Stewart Tepper, Vice President of the New England Institute for Neurology and Headache, highlighted that the results align with outcomes from traditional preventive migraine medication trials. He noted that the introduction of CT-132 could greatly benefit patients by providing an additional non-pharmacological treatment option that complements existing migraine medications.

Migraines are a significant health issue, affecting over 37 million adults in the United States and ranking as the second leading cause of disability. These severe headache episodes often come with nausea and increased sensitivity to light and sound, severely impacting various aspects of life including work, education, and personal relationships.

Despite the availability of preventive medications, many patients continue to suffer from regular and debilitating migraine attacks. CT-132 aims to fill this gap in migraine management. It is designed to function alongside existing medications to reduce brain hypersensitivity to environmental and internal triggers, thereby helping patients better manage their daily activities.

The efficacy and safety of CT-132 were evaluated in two Phase III trials designed to mirror contemporary randomized control trials for migraine drugs. Notably, these studies allowed patients to continue their existing medications, thereby assessing the additive effect of CT-132.

Austin C. Speier, Chief Strategy Officer at Click Therapeutics, mentioned that the combination of traditional drugs with software, as demonstrated by CT-132, aligns with recent FDA guidance on Prescription Drug Use-Related Software (PDURS). This approach could lead to an integrated therapy offering added clinical benefits, simplifying the experience for patients, prescribers, and payers.

Click Therapeutics plans to present their findings at major medical conferences and publish them in peer-reviewed journals. CT-132 is still investigational and has not yet been approved for sale in the United States.

Click Therapeutics is a leading innovator in developing, validating, and commercializing software as prescription medical treatments. Their mission is to provide accessible, clinically validated treatments through smartphones and other digital platforms, addressing unmet medical needs across various therapeutic areas.

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