Click Therapeutics Initiates Fully Remote Pivotal Trial Using Investigational Prescription Digital Therapeutics to Treat Episodic Migraine
• The ReMMi-D trial will evaluate the efficacy and safety of investigational prescription digital therapeutics for the prevention of episodic migraine in patients 18 years and older.
• Fully decentralized, randomized clinical trial enrolling approximately 558 participants reflects the company’s commitment to innovating digital therapeutics that address high unmet patient need in serious indications, such as migraine.
• The Click Therapeutics platform enables the development and validation of new digital therapeutics that have significant potential to reduce barriers to care and expand patient access to new, additive treatment types that can improve health outcomes.
NEW YORK – April 20, 2023 – Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the ReMMi-D, Reduction in Monthly Migraine Days study, a fully remote and decentralized pivotal trial designed to investigate the efficacy and safety of prescription digital therapeutics in reducing the number of monthly migraine days for adults diagnosed with episodic migraine.
Migraine is a complex and debilitating condition that affects more than 40 million adults1,2, and is the second leading cause of disability in the United States3. Migraine is characterized by episodes of moderate-to-severe headache and generally associated with nausea and increased sensitivity to light and sound4. Its burden is impacted by employment status, poverty, education attainment and insurance coverage.4,5 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.
Unlike a traditional clinical trial in which a patient receives treatment at a designated clinical trial site, ReMMi-D is a completely remote study in which patients receive digital therapy through a mobile application while going through their regular daily activities and allows for a more representative patient population for enrollment. This study design is consistent with the real-world potential of prescription digital therapeutics to reduce barriers to care by enabling access to therapy for patients anywhere, irrespective of geographic location or proximity to trained specialists.
“Enrolling the first patient in our ReMMi-D pivotal study marks Click Therapeutics’ continued progress toward developing first-in-class, prescription digital therapeutics for patients living with migraine,” said Austin Speier, Chief Strategy Officer of Click Therapeutics. “We are driven by our commitment to using digital technology to enable novel approaches that can provide additional treatment options to patients suffering with migraine, fulfilling unmet patient needs and delivering on better patient outcomes.”
The Phase 3, randomized, double-blind trial will enroll approximately 558 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 (MMDs).
“We are pleased and excited to have launched a pivotal trial to validate new ways of helping patients with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “We are hoping to support not only the 40 million people with migraine, but also the extensive network of primary care providers and fellow neurologists who are at the forefront battling this disease.”
Click will present an abstract titled Positive establishment of a digital working alliance with a prescription digital therapeutic in patients with migraine at the 75th Annual Meeting of the American Academy of Neurology (AAN) taking place in Boston from April 22nd to 27th. The team will be presenting Click’s migraine phase 2, Clinical Learning Study (CLS) results, introducing the concept of PDTs to fellow neurologists, and sharing data on how a positive Digital Working Alliance results in robust engagement.
"Our team has worked diligently to develop this groundbreaking technology and we are excited to be at the forefront of medicine's digital revolution," said Han Chiu, Chief Technology Officer of Click Therapeutics. "We believe that our platform-based approach harnessing the power of data, AI, and exceptional product design will lead to a best-in-class treatment for migraine that can improve the lives of patients worldwide."
FDA Breakthrough Device Designation
In December 2022, Click Therapeutics received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the adjunctive preventive treatment for episodic migraine in patients aged 18 years and older. The Breakthrough Devices Program is intended for devices that have potential to provide more effective treatment over the existing standard of care for life-threatening or irreversibly debilitating diseases. The program is designed to expedite the development and review of medical devices meeting Breakthrough criteria in the United States.
About Click Therapeutics
Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, we deliver accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Digital therapeutics under development on our platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, cardiology and immunology. Consistently named a best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our mission to provide patients everywhere access to safe and effective prescription digital therapeutics.
For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.
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2 . GlobalData. (2021). Migraine – Epidemiology Forecast to 2030. https://www.globaldata.com/store/report/migraine-epidemiology-analysis/
3 . American Migraine Foundation. (2020). How to Apply for Social Security Disability Insurance with Migraine https://americanmigrainefoundation.org/resource-library/ssdi-migraine/ [Accessed 09/29/2022]
4 . Torres-Ferrús, M., Ursitti, F., Alpuente, A., Brunello, F., Chiappino, D., de Vries, T., Di Marco, S., Ferlisi, S., Guerritore, L., Gonzalez-Garcia, N., Gonzalez-Martinez, A., Khutorov, D., Kritsilis, M., Kyrou, A., Makeeva, T., Minguez-Olaondo, A., Pilati, L., Serrien, A., Tsurkalenko, O., Van den Abbeele, D., van Hoogstraten, W.S. & Lampl, C. On behalf of School of Advanced Studies of European Headache Federation (EHF-SAS). (2020). From transformation to chronification of migraine: pathophysiological and clinical aspects. J Headache Pain 21, 42 (2020). https://doi.org/10.1186/s10194-020-01111-8
5 . Burch R. (2021). Preventive Migraine Treatment. Continuum (Minneapolis, Minn.), 27(3), 613–632. https://doi.org/10.1212/CON.0000000000000957. Erratum in: Continuum (Minneap Minn). 2021 Oct 1;27(5):1494-1495. PMID: 34048395