Click Therapeutics announced that CT-132 met its primary endpoint in the phase 3 ReMMi-D trial.
Positive results have been announced from a phase 3 trial evaluating the efficacy and safety of the digital therapeutic CT-132 for the preventative treatment of migraine in adult patients, Click Therapeutics announced in a release.1 The therapy, which is intended to be taken with existing medication, could provide additional clinical data that can benefit patients.
Digital Therapeutic Shows Significant Reduction in Episodic Migraine / goodluz - stock.adobe.com
Data from the ReMMi-D (NCT05853900) study showed that CT-132 met its primary endpoint of change in monthly migraine days. The therapeutic also met key secondary endpoints, including change from baseline in Migraine-Specific Quality-of-Life Questionnaire (MSQ) and change from baseline in Migraine Disability Assessment (MIDAS).
Trial Name: Study of Two Digital Therapeutics for the Prevention of Episodic Migraine
Clinicaltrials.gov Identifier: NCT05853900
Sponsor: Click Therapeutics
Summary: The purpose of this randomized ReMMi-D trial is to evaluate the efficacy and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults.
CT-132 is a prescription digital therapeutic that is meant to be used alongside existing migraine medications in adult patients. The product delivers a proprietary 12-week clinical intervention that is designed to reduce brain hypersensitivity by modulating responses to environmental and internal stimuli. This helps patients by giving them the ability to engage in daily activities more fully.
“The clinical data demonstrate a successful reduction in monthly migraine days, which was the primary endpoint, as well as improving quality of life and reducing disability,” Stewart Tepper, MD, vice president of the New England Institute for Neurology and Headache said in a release.1 “This is the first migraine digital therapeutic to be studied with this degree of rigor, and the availability of CT-132 would be a very useful addition to our migraine armamentarium providing additional benefit to patients on migraine medication and expanding access to non-pharmacological treatment options.”
ReMMi-D was a randomized, double-blind, parallel-group, virtual phase 3 study evaluating the efficacy and safety of 2 prescription mobile applications for preventative treatment of episodic migraine in late adolescents and adults. The study cohort included 568 patients who randomly received either 1 of 2 digital therapies through a mobile application over a 12-week period as they went about normal daily activities.2
The study found that patients who received CT-132 had a statistically significant reduction in monthly migraine days (MMDs), experiencing -3.04 MMDs by the end of treatment. The digital therapy improved MSQ from week 4 through week 12, and improved MIDAS by the end of the study period. Patients who received the therapy also reported improvements in their health as measured by the Patient Global Impression-Change (PGI-C). Additionally, patient engagement and adherence to the therapy were high and sustained throughout the 12 weeks. CT-132 was seen to be well tolerated, with no treatment-related adverse events observed during the study.
ReMMi-D was further supported by the ReMMiD-C (NCT06004388) study. The phase 3 bridging study evaluated the efficacy and safety of CT-132 for the preventative treatment of migraine in 110 late adolescents and adults who were receiving calcitonin gene-related peptide (CGRP) inhibitor therapy.
"This is a significant milestone for more than one billion people worldwide living with migraine,” Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics, said in a release.1 “Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”
According to data from the CDC, 4.3% of adults in 2021 reported being bothered a lot by headache or migraine in the past 3 months.3 The neurological disorder is characterized by episodes of moderate-to-severe headaches that can last hours to days. Migraine, which can significantly impact daily activities, can be triggered by stress, hormonal changes, specific foods, and environmental influences.4
READ MORE: Headache and Migraine Resource Center
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