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Abstract Details

Efficacy and Safety of a First-in-Class Investigational Prescription Digital Therapeutic for Episodic Migraine (CT-132): Phase 3 Double-Blind, Randomized, Controlled Trial
Headache
P4 - Poster Session 4 (5:00 PM-6:00 PM)
12-006
Evaluate the safety and effectiveness of CT-132 in adults with episodic migraine (EM).
Migraine affects more than 40 million Americans and is the second-leading worldwide cause of disability. Despite advancements in pharmacotherapy, partial treatment response is common, driving an unmet need for additional reductions in monthly migraine days (MMDs). Prescription digital therapeutics (PDTs) can meet this need without adverse events or polypharmacy concerns common to pharmacotherapies. We report the results of Reduction in Monthly Migraine Days (ReMMi-D), a phase 3 trial of the investigational PDT CT-132 for the preventive treatment of EM in adults.
ReMMi-D was a 12-week, double-blind, randomized, controlled trial (RCT) assessing effectiveness and safety of CT-132 for preventive treatment of EM, adjunctive to acute and/or non–migraine-specific preventive medications. Participants aged ≥18 years with 4–14 MMDs during the run-in period were randomized to receive CT-132 or a sham digital therapeutic. The primary outcome was change in MMDs from the 4 weeks of run-in to the final 4 weeks of the intervention period. Additional outcomes included headache frequency, quality of life (QOL), disability, patient global impression of change, and safety. 
Of the 570 enrolled participants, 286 were randomized to CT-132 and 284 to sham. In the intent-to-treat population, after 12 weeks CT-132 significantly reduced MMDs compared to sham (least-squares mean [LSM] treatment difference, –0.90 MMDs, 95% CI, –1.53,–0.27, P=0.005) and monthly headache days (MHDs) (LSM treatment difference, –0.85 MHDs, 95% CI, –1.53,–0.16, P=0.015). Participants receiving CT-132 compared to those receiving sham reported statistically significant reductions in disability and improvements in QOL and migraine condition. No adverse events were related to treatment.
Results from ReMMi-D establish CT-132 as a safe and effective first-in-class investigational PDT that delivers meaningful outcomes for adults with EM beyond those achieved with prescription medication alone.
Authors/Disclosures
Cassandra Snipes, PhD
PRESENTER 		Ms. Snipes has received personal compensation for serving as an employee of Click Therapeutics.
Alexander Kuka (Click Therapeutics) Dr. Kuka has received personal compensation for serving as an employee of Click Therapeutics, Inc..
Mariya Petrova (Click Therapeutics) Mariya Petrova has received personal compensation for serving as an employee of Click Therapeutics. Mariya Petrova has received research support from NIH.
Timothy Peters-Strickland, MD Dr. Peters-Strickland has received personal compensation for serving as an employee of Click Therapeutics. Dr. Peters-Strickland has received personal compensation for serving as an employee of Thermo Fisher Scientific. Dr. Peters-Strickland has received publishing royalties from a publication relating to health care.
Laura Taraboanta, MS Ms. Taraboanta has received personal compensation for serving as an employee of Click Therapeutics.
Olya Besedina (Click Therapeutics Inc.) Miss Besedina has nothing to disclose.
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache) Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atheneum. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axsome Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Becker Pharmaceutical Consulting. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clearview Healhcare Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CoolTech. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CRG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resources. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Defined Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DRG. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ExpertConnect. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fenix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Advances. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Science Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Communications. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InteractiveForums. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Keyquest. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Krog and Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magnolia Innovation. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJH Holdings. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for P Value Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pain Insights Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Palion Medical. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulmatrix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Putnam Associates. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAI MedPartners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spherix Global Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Strategy Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for System Analytic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Taylor and Francis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UnityHA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for XOC. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Click Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurofront Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rehaler. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Tepper has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Pfizer. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alphasights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Scilex. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communication. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tegus. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Catch Therapeutics. Dr. Tepper has received personal compensation in the range of $0-$499 for serving as a Consultant for DocDelta. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dr Reddy's. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gilmartin Capital. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Initiator Pharma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magellan Health. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nocira. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Third Bridge. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tonix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vial . Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DocDelta. The institution of Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch Health. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dr Reddy's. The institution of Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ClickTherapeutics. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CoolTech. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miravo Healthcare. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pulmatrix. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Tepper has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Pfizer. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Scilex. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Tonix. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Dr Reddy's. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Anneal. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. The institution of Dr. Tepper has received research support from Abbvie. The institution of Dr. Tepper has received research support from Aeon. The institution of Dr. Tepper has received research support from Amgen. The institution of Dr. Tepper has received research support from Annovis. The institution of Dr. Tepper has received research support from Axsome. The institution of Dr. Tepper has received research support from Cassava. The institution of Dr. Tepper has received research support from Cognition. The institution of Dr. Tepper has received research support from Eli Lilly. The institution of Dr. Tepper has received research support from Inibikase. The institution of Dr. Tepper has received research support from Ipsen. The institution of Dr. Tepper has received research support from Lundbeck. The institution of Dr. Tepper has received research support from Merz. The institution of Dr. Tepper has received research support from Pfizer. The institution of Dr. Tepper has received research support from PrecisionMed. The institution of Dr. Tepper has received research support from Revance. The institution of Dr. Tepper has received research support from Suven. The institution of Dr. Tepper has received research support from UCB. The institution of Dr. Tepper has received research support from Biohaven. The institution of Dr. Tepper has received research support from Johnson and Johnson/Intracellular. The institution of Dr. Tepper has received research support from Karuna. The institution of Dr. Tepper has received research support from Neurocrine. Dr. Tepper has received publishing royalties from a publication relating to health care. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a CME Speaker with Diamond Headache Clinic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical 好色先生 Speakers Network. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Miller Medical Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Physicians' 好色先生 Resource. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a CME Speaker with WebMD/Medscape. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with American Headache Society. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Vindico Medical 好色先生. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with HMP Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CMe speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with Consortium for Research 好色先生 Social Awareness and Training In Neurosciences.
Shaheen E. Lakhan, MD, PhD, MEd, FAAN Dr. Lakhan has received personal compensation for serving as an employee of Zogenix, Fern Health, Thriveworks, The Learning Corp, TriNet, Click Therapeutics. Dr. Lakhan has received personal compensation in the range of $1,000,000+ for serving as a Consultant for Shaheen Lakhan, MD, PhD, LLC. Dr. Lakhan has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurocrine, Fern Health, Lin Health. Dr. Lakhan has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Click Therapeutics, SpineThera. Dr. Lakhan has stock in Zogenix, NeuroSport, Click Therapeutics, SpineThera.