drugset / Trial / NCT00125138
Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.
Timeline
- Start
- 2005-07
- Primary completion
- 2008-03
- Completion
- 2008-04
Outcome
Missed primary endpoint
registry Melperone HCl - 40 mg vs Placebo; p = 0.1519; Difference of LS mean -2.9 (95% CI -8.5 to 2.7); ANCOVA NCT00125138 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melperone | Small molecule | 20 mg | — |
| Subject | Melperone | Small molecule | 40 mg | — |
| Subject | Melperone | Small molecule | 60 mg | — |