GERMANTOWN, Md. -- (BUSINESS WIRE) -- Psyadon Pharmaceuticals, Inc. announced today the opening of the first four centers in a new Phase 2b clinical trial of ecopipam for the treatment of Tourette’s Syndrome in children ages 7 to 17.
“We are excited to start this double-blind, placebo-controlled trial in children with Tourette’s Syndrome,” said Dr. Richard Chipkin, President and CEO of Psyadon. “The previous positive results from our open label study in adults with Tourette’s have encouraged us to move into this younger population where treatments with new mechanisms are desperately needed.”
The study’s Principal Investigator, Dr. Donald Gilbert (Cincinnati Children’s Hospital Medical Center) said “This study is vital to understanding whether ecopipam could be an effective treatment for Tourette’s. If positive, it will provide hope for hundreds of sufferers who have few good options.”
ABOUT THE PSY302 STUDY
Protocol PSY302 is a multicenter, double-blind, placebo-controlled, randomized two-way crossover study designed to assess the efficacy and safety of ecopipam in subjects with Tourette’s Syndrome. Eligible subjects are instructed to take ecopipam (50 or 100 mg/day depending on body weight) or placebo before bedtime over an 8-week treatment period (comprised of two four-week treatment periods with either ecopipam or placebo). Due to the crossover design, all subjects will receive active medication at some time during the study. Efficacy will be measured using the Yale Global Tic Severity Scale, a well-validated, standard rating scale typically used when testing new pharmaceuticals. See www.clinicaltrials.gov for further information.
The following sites are open and enrolling patients: Cincinnati Children’s, Cincinnati OH (Dr. Donald Gilbert), North Shore Hospital, Manhasset, NY (Dr. Cathy Budman), Overlook Medical Center, Summit, NJ (Dr. Roger Kurlan), and Emory University, Atlanta, GA (Dr. Jorge Juncos). Additional centers expected to open shortly include Baylor College of Medicine, Houston TX (Dr. Joseph Jankovic) and Johns Hopkins University, Baltimore MD (Dr. Harvey Singer). It is anticipated that sites in New York City and Florida will open later this year.
Ecopipam is a first-in-class molecule that selectively blocks the actions of the neurotransmitter dopamine at its receptor. Dopamine receptors can be broadly classified into two families based on their structures (“D1 receptors” and “D2 receptors”). Ecopipam blocks dopamine only at D1 receptors. In contrast, all currently marketed dopamine antagonists and agonists act at D2 receptors.
Based on studies in a large number of patients and normal volunteers, ecopipam is generally well-tolerated. Results from a previous Phase 2a study in adults with Tourette’s has suggested that ecopipam may be an effective treatment.
ABOUT PSYADON PHARMACEUTICALS
Psyadon Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the discovery and development of drugs for serious neurological and psychiatric disorders. The company focuses its efforts on drugs for orphan indications because of the high medical need for effective treatments. Psyadon has received orphan designation from US regulatory authorities for the use of ecopipam to treat Tourette’s Syndrome in children ages 7-17.