drugset / Trial / NCT00310661

Sarizotan in the Treatment of Neuroleptic-induced Tardive Dyskinesia

NCT00310661

RandomizedParallel-groupQuadruple-blindTreatment

Summary

TD is a troublesome and potentially irreversible side effect associated with the use of neuroleptics. While the newer neuroleptics are improved in this regard, they all still carry the risk of TD. The present study proposes that sarizotan is a potential agent for treating neuroleptic-induced TD based on preliminary data indicating efficacy in the management of dyskinesias associated with Parkinson's disease. Its efficacy is further substantiated by pre-clinical data obtained from the vacuous chewing movement (VCM) model in rats, a model we employ ourselves in investigating the relationship between D2 occupancy and TD. The present study also examines the effects of sarizotan on cognitive function, given the association between TD and cognitive deficits.

Timeline

Start
2004-12
Primary completion
2006-09
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sarizotan Small molecule 2 mg Oral
Subject Sarizotan Small molecule 5 mg Oral
Subject Sarizotan Small molecule 7 mg Oral

Indications