The Tourette Syndrome Association (TSA) and Psyadon have announced a clinical trial to determine the potential efficacy of ecopipam for managing the symptoms of Tourette Syndrome (TS).
“This marks the beginning of a new phase in our efforts to facilitate the development of effective and safe medications that are urgently needed for people with TS,” said Judit Ungar, president of TSA. The TSA will assist with subject recruitment for the clinical trial of ecopipam, the rights to which are owned by Psyadon. Ecopipam was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) in September 2010.
“Experiments in animals suggest that ecopipam, which belongs to a class of agents referred to as dopamine D1 antagonists, interacts with nerve cells and systems in the brain that are thought to contribute to the development of tics and other symptoms in TS,” says Richard Chipkin, president and chief executive officer of Psyadon. “Based on these studies, there is a good rationale and a logical basis for examining this drug’s efficacy in reducing tic severity in individuals with TS.”
The clinical trial is a Phase 2a, open-label, non-randomized trial to examine the ability of ecopipam to both reduce tic severity and determine its safety in individuals (18 to 65 years of age) with TS. The study is being conducted at four sites across the U.S. by leading experts in the field of TS and is expected to last for several months. Psyadon and TSA anticipate the data from this clinical trial will be released by mid 2012.
Release Date: May 11, 2011Tourette Syndrome Association
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