The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone (20, 40, and 60 mg) in the syrup formulation compared to placebo in the treatment of psychosis associated with Parkinson’s Disease. Subjects will be enrolled at approximately 15 investigational sites in the U.S. The maximum study duration will be 10 weeks including a 1-2 week Screening/Washout Period, a 5 week Titration Phase, a 1 week Maintenance Phase and a Taper/Follow-up Period up to 2 weeks. Subjects will have the option of continuing in an open-label extension study.

Condition	Intervention	Phase
Parkinson Disease Psychotic Disorders	Drug: melperone HCl	Phase II

Further Study Details: 

Primary Outcomes: Safety; Efficacy
Secondary Outcomes: Pharmacokinetic; Dose Ranging
Expected Total Enrollment:  90

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

- The subject or subject’s legally authorized representative (LAR) must sign and date the IRB/IEC approved Informed Consent/HIPAA Authorization form prior to study participation.

- Subjects with a clinical diagnosis of idiopathic Parkinson’s Disease, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:

• Rest tremor

• Rigidity

• Bradykinesia and/or akinesia

• Postural and gait abnormalities

- Subjects with psychosis:

• Presence of visual and/or auditory hallucinations, with or without delusions, occurring during the four weeks prior to the Screening Visit.

• Symptoms severe enough to clinically warrant treatment with an antipsychotic agent.

• A Hallucinations or Delusions item score of = > 4 on the Neuropsychiatric Inventory (NPI).

Exclusion Criteria:

- Subject has a history of significant psychotic disorders prior to the diagnosis of Parkinson’s Disease, including but not limited to schizophrenia or bipolar disorder.

- Subject has dementia or a major depressive disorder precluding accurate assessment on rating scales.

- A score on the Mini-Mental State Examination (MMSE) of <21.

- Subject has had a dose adjustment in their antidepressant medication within the 30 days prior to the Screening Visit, or dose adjustments are planned during the duration of the trial.

- Subject has had dose adjustments in an anxiolytic, cognitive enhancer, or other psychotropic medication (excluding antipsychotics) within 30 days prior to the Screening Visit or dose adjustments are planned during the duration of the trial.

- Subject has a history of a serious respiratory, gastrointestinal, renal, hematologic or other medical disorder.

- Subject has a history of a serious cardiovascular condition (including, but not limited to, Class IV angina, Class IV heart failure or subjects with permanent pacemakers) and/or a history of risk factors for Torsade de pointes (TdP) (including, but not limited to current treatment for hypokalemia or family history of long QT syndrome)

- Subject has a screening ECG with corrected QT interval by Bazett’s correction formula (QTcB) of greater than 430 msec, if female, or 450 msec, if male, or a QRS duration > 120 msec.

- Subject requires treatment with an α-agonist agent

Randomization

- Subject has a hallucinations or delusions item score of = > 4 on the (NPI).

- Subject has remained on a stable dose of anti-parkinsonian medications.

- Subject has not had a dose adjustment in their antidepressant medication since the screening visit.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125138

Richard G Moore, B.Sc      847-282-1000    rmoore@ovationpharma.com

California
      The Parkinson’s and Movement Disorder Institute, Fountain Valley,  California,  92708,  United States; Not yet recruiting
Florida
      Bradenton Research Center, Inc, Bradenton,  Florida,  34205,  United States; Recruiting
Michigan
      Quest Research Institute, Bingham Farms,  Michigan,  48025,  United States; Recruiting
Texas
      Future Search Trials, Austin,  Texas,  78756,  United States; Recruiting

Study chairs or principal investigators

Katherine A Tracy, M.D.,  Study Director,  Ovation Pharmaceuticals   

Study ID Numbers:  OV-1003
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125138
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02