NCT00686699

Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)

A Phase 2a, Multiple Dose, Placebo Controlled, Randomized, Two Way Crossover Study to Assess the Efficacy of SCH 420814 in Reducing Anti Psychotic-Induced Extra Pyramidal Symptoms Among Subjects With Schizophrenia and Schizoaffective Disorders

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom Rating Score (ESRS), was to be evaluated frequently during the treatment periods.

Conditions

• Akathisia, Drug-Induced
• Dyskinesia, Drug-Induced
• Parkinsonian Disorders

Interventions

Type	Name	Description
DRUG	Preladenant	capsules
DRUG	Placebo	capsules

Timeline

• Start date: 2006-07-10
• Primary completion: 2008-03-06
• Completion: 2008-03-06
• First posted: 2008-05-30
• Last updated: 2018-11-09
• Results posted: 2016-12-07