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Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease

NCT00125138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-06-17

Study results available
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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.

Conditions

Interventions

DRUG

Melperone HCl

20 mg/day. Strength of melperone syrup is 5 mg/mL

DRUG

Melperone HCl

40 mg/day. Strength of melperone syrup is 5 mg/mL

DRUG

Melperone HCl

60 mg/day. Strength of melperone syrup is 5 mg/mL

DRUG

Placebo

Syrup formulation

Sponsors & Collaborators

  • Lundbeck LLC

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-03-31
Completion
2008-04-30

Countries

  • United States
  • India
  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125138 on ClinicalTrials.gov