Columbia Care and The Center for Discovery announced a partnership to study the efficacy of Columbia Care's proprietary, dose metered, full-spectrum high cannabidiol (CBD) and ultra-high CBD tablets, ClaraCeed and ClaraCeed Ultra, in treating qualifying pediatric and adult patients with intractible epilepsy who choose to use Columbia Care products.
The research team will be led by Orrin Devinsky, M.D., professor of neurology, neurosurgery and psychiatry at NYU School of Medicine and medical director of NYU Langone's Comprehensive Epilepsy Center. Dr. Devinsky served as principal investigator for the Epidiolex trials in the United States that ultimately led to FDA approval of the first cannabis-derived drug for the treatment of two rare forms of epilepsy.
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"The Center for Discovery has been advancing care and research for complex conditions for many decades. We hope that this research, drawing on the expertise of Dr. Devinsky and The Center for Discovery's renowned medical team, will advance the treatment of drug-resistent epilepsy and have implications far beyond our community at The Center for Discovery," said Dr. Terry Hamlin, associate executive director at The Center and key investigator on this study.
"This partnership highlights Columbia Care's dedication to evidence-based research validating the therapeutic benefits of our precisely manufactured cannabis-derived medicines. We are honored to have been selected as a partner by the prestigious Center for Discovery as well as to have the opportunity to collaborate with such a world-renowned epilepsy expert as Dr. Devinsky,” Rosemary Mazanet, M.D., Ph.D., chief scientific officer and chair of the scientific advisory board at Columbia Care said. “We are looking forward to better understanding how our ClaraCeed and ClaraCeed Ultra medications can best be utilized to treat patients who are suffering from treatment-resistant epilepsy safely and effectively."
The observational study will enroll fifty Center for Discovery patients with drug-resistant epilepsy, aged 8-40 years old, who choose Columbia Care as their medical cannabis provider in accordance with current New York State Department of Health guidelines. The study will evaluate the optimal dose for safety, tolerability and potential reduction of convulsive seizures using ClaraCeed and ClaraCeed Ultra medical cannabis tablets as an adjunct treatment in children and adults with drug resistant epilepsy.