Dr. Vince Clinical Research (DVCR), a full-service clinical research organization (CRO), today announced the first dosing in Cingulate Therapeutics’ CTx-1301 Phase III dose-optimization onset and duration laboratory classroom study. This study is taking place in pediatric patients ages 6-12 with attention-deficit/hyperactivity disorder (ADHD) and also marks the launch of DVCR’s multisite clinical trial offering to biopharmaceutical companies.
“Several of our key clients have encouraged us to offer a multicenter clinical trial solution for their drug development programs after they have completed other early phase studies at our company,” said Brad Vince, D.O., CEO & medical director. “We have strategically expanded our team with experts who will enable us to make an impact in this space and for this multisite trial partnership with Cingulate Therapeutics.”
Cingulate Therapeutics is developing CTx-1301 (dexmethylphenidate) to fulfill unmet needs of patients with ADHD, utilizing the company’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology. This technology provides the ability for the medication to achieve entire active-day efficacy with a fast onset of action, eliminate the need for additional doses of short-acting stimulant medications called “boosters,” improve tolerability and minimize the “rebound” or “crash” symptoms that are associated with early medication “wear-off.”
Shane J. Schaffer, Pharm.D., chairman and CEO of Cingulate, stated, “It’s a privilege to collaborate again with Dr. Vince and the team at DVCR as we proceed with the remainder of our CTx-1301 Phase III program. We believe that once completed, the results from this classroom study, along with that from our pivotal Phase III trial, will allow us to submit a New Drug Application for CTx-1301 in the second half of 2024, and continue our mission to offer patients, physicians and payors a next-generation ADHD product which provides exceptional treatment.”
The CTx-1301 Phase III laboratory classroom study is being conducted at multiple U.S. sites and plans to enroll 85 pediatric ADHD study volunteers. The purpose of this trial is to facilitate repeated observational measures of attention, deportment and cognitive performance as well as allows for documented assessments of drug effects over multiple timepoints during the classroom day.
“These studies require unique expertise and infrastructure that are found at only a limited number of sites across the country,” Dr. Vince said. “Fortunately, we were able to quickly identify and qualify sites to execute this challenging study due to our established investigator relationships and proactive project management team.”
DVCR looks forward to successfully completing this multisite trial in partnership with Cingulate Therapeutics and extending this offering to additional biopharmaceutical sponsors.
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and multiple therapeutic areas such as neuroscience, psychiatry, substance abuse, pain, cardiometabolic disorders, infectious diseases and others. CRO services include project management, data management, biostatistics, monitoring, PK/PD analysis, medical writing as well as site feasibility and management for multi-center trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
Contacts
Zach Bader
Vice President, Business Development
913-333-3000
info@drvince.com