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

Sponsored by:	Ovation Pharmaceuticals
Information provided by:	Ovation Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00125138

Purpose

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.

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Psychotic Disorders

Drug Information available for: Melperone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease

Further study details as provided by Ovation Pharmaceuticals:

Primary Outcome Measures:

Patient evaluation of symptoms of psychosis [ Time Frame: Baseline through Maintenance Period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator/Caregiver evaluations of symptoms of psychosis [ Time Frame: Baseline through Maintentance Period ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	July 2005
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Low Dose	Drug: melperone HCl Syrup formulation (5 mg/ml)
2: Experimental Medium Dose	Drug: melperone HCl Syrup formulation (5 mg/ml)
3: Experimental High Dose	Drug: melperone HCl Syrup formulation (5 mg/ml)
4: Placebo Comparator	Drug: Placebo Syrup Formulation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject or subject's legally authorized representative (LAR) must sign and date the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approved Informed Consent/Health Insurance Portability and Accountability Act (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 his/her 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 or Class IV heart failure) 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 electrocardiogram (ECG) with corrected QT interval by Bazett's correction formula (QTcB) of greater than 450 msec, if female; or 430 msec, if male.
Subject requires treatment with an α-agonist agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125138

Show 21 Study Locations

Sponsors and Collaborators

Ovation Pharmaceuticals

Investigators

Study Director:

Katherine A Tracy, M.D.

Ovation Pharmaceuticals

More Information

Responsible Party:	Ovation Pharmaceuticals ( Diane LeComte/Assistant Director Clinical Operations )
Study ID Numbers:	OV-1003
Study First Received:	July 27, 2005
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00125138
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Metylperon
Schizophrenia

Parkinson Disease
Movement Disorders
Mental Disorders
Psychotic Disorders
Parkinsonian Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009