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news.Transcept Pharmaceuticals has completed patient enrolment in Phase 2 trial of TO-2061, a low dose formulation of ondansetron, a serotonin subtype 3 (5-HT3) receptor antagonist, added as adjunctive therapy for obsessive compulsive disorder (OCD).
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The trial will evaluate safety and efficacy of TO-2061 added as adjunctive therapy in 168 OCD patients who have not adequately responded to first-line treatment with an approved OCD medication.
Patients with a documented history of at least six weeks of inadequate response to an approved OCD medication continued to receive that first line OCD medication during an additional 6-week run-in phase of the trial.
Patients who failed to respond during the run-in phase were eligible to be randomised to the 12 week double-blind active treatment phase, during which they will continue to receive first line medication with the addition of ondansetron 0.5mg twice per day, ondansetron 0.75mg twice per day or placebo twice per day, according to the company.
The difference between active and placebo treatment arms in the change from baseline as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the primary endpoint of the study.
The company expects top-line results of the double-blind, placebo-controlled study in the first quarter of 2013.