Tourette's Syndrome (TS) is a neurological disease characterized by motor or vocal tics that begin in childhood and persist over time. The tics are brief in duration, occur spontaneously, and do not show a regular temporal pattern. Further the tics are not caused by medications, other medical reasons, or confirmed tissue damage. They can be consciously suppressible and are exacerbated by stress. Males are more susceptible than females with a ratio of about 3 to 4:1. Motor tics can include such things as eye-blinking, facial grimacing, mouth movements, head jerks, shoulder shrugs and arm/leg jerks. In more severe cases gyrating, bending, pivoting and dystonic movements are possible. Vocal tics are fast meaningless sounds or noises, and include such things as sniffing, throat clearing, grunting, barks and squealing. Complex vocal tics can include shouting out of single words, whole sentences or repeating words (echolalia). In small numbers of patients, explosive obscenities (coprolalia) are possible.Based on the scientific literature there is reason to believe that ecopipam may relieve the symptoms of TS.
Psyadon initiated a multi-center open-label Phase 2a clinical trial to determine the safety and activity of ecopipam for the treatment of adult patients with Tourette's Syndrome. Psyadon announced on July 24, 2012, that due to positive results this clinical trial was terminated early. Please see the Press Releases webpage for additional information.
Ecopipam for the Treatment of Tourette's Syndrome in Children Ages 7-17
Based on the positive results of our previous study showing that ecopipam significantly reduced the symptoms of Tourette's Syndrome in adults, Psyadon Pharmaceuticals has started a Phase 2b study in children. This new study (called PSY302) is a multicenter, double-blind, placebo-controlled, randomized two-way crossover study designed to assess the efficacy and safety of ecopipam in children (ages 7-17) 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.
This trial has successfully completed. Ecopipam showed statistically significant reductions in symptoms at both two- and four-weeks when ratings were done. Ecopipam showed good tolerability with no changes in clinical lab tests, ECG's, blood pressure, vital signs or body weights.
Psyadon would like to thank the participants of this trial.