Migraine is a complex and debilitating condition that affects more than 47 million Americans,1 and is the second leading cause of years lived with a disability.2 For those living with migraine, attacks unfold over hours to days and negatively impact many domains including employment, educational attainment, and relationships.3 Despite its prevalence, migraine remains a disorder with high unmet need due to incomplete remission and lack of access to specialty care.
Click Therapeutics, a leader in Digital Therapeutics™, has developed CT-132, a prescription digital therapeutic being developed as an adjunctive preventive treatment for episodic migraine in adults 18 years and older. Delivered through a mobile app, CT-132 leverages digital neuroactivation and modulation (DiNaMo) techniques to reduce brain hypersensitivity, a key factor in migraines. Over a 12-week program, the app combines neurobehavioral interventions with adaptive patient engagement to modulate neural pathways and decrease susceptibility to migraine triggers. Designed to complement existing treatments, CT-132 aims to reduce the number of monthly migraine days and improve patients’ quality of life through a non-pharmacological, personalized approach.
The randomized, double-blind, controlled study, named ReMMi-D (Reduction in Monthly Migraine Days), demonstrated that CT-132 significantly reduced monthly migraine days (MMDs) compared to a sham treatment over a 12-week period. Patients in the treatment group experienced an average reduction of 3.04 MMDs, achieving the primary endpoint of the study with a statistically significant difference of -0.9 MMDs compared to the sham group (p=0.005).
In addition to reducing the frequency of migraine days, CT-132 showed improvements in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) and Migraine Disability Assessment (MIDAS), with notable benefits observed as early as four weeks into the treatment. Furthermore, patients reported enhanced overall health as measured by the Patient Global Impression – Change (PGI-C) at the end of the trial (p<0.001). The study’s robust engagement and adherence rates highlight the potential for CT-132 to offer a viable, non-pharmacological option for migraine prevention.
This development is significant for the over one billion people globally who suffer from migraines, a condition that remains a major cause of disability despite existing treatments. The innovative approach of CT-132, which modulates patient responses to environmental and internal stimuli to reduce brain hypersensitivity, represents a new frontier in migraine management. It is designed to be used alongside existing medications, providing an additional layer of treatment without the need for a washout period of current therapies.
Dr. Shaheen Lakhan, Chief Medical Officer of Click Therapeutics, emphasized the breakthrough nature of CT-132, which has the potential to offer patients a novel therapeutic option accessible through any smartphone. The successful results from the ReMMi-D study, supported by a recent bridging study (ReMMiD-C), pave the way for advancing CT-132 through regulatory channels, with hopes of securing FDA clearance.
CT-132’s success in the clinical trials positions it as the first digital therapeutic rigorously tested for migraine prevention, promising to expand the current treatment landscape. The company plans to present its findings at major medical conferences and pursue further development of its digital therapeutic pipeline, potentially integrating these with traditional pharmacological treatments.
Article written by Business Wire
04/09/2024
Source:
Business Wire
https://www.businesswire.com/news/home/20240904512812/en/Click-Therapeutics-Announces-CT-132-Met-Primary-Endpoint-for-the-Reduction-of-Monthly-Migraine-Days-in-ReMMi-D-Pivotal-Trial