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.
Parkinson's Disease is a progressive neurodegenerative disorder characterized by bradykinesia, rigidity, tremor and abnormal posture and gait. Many patients can have mild to moderate symptoms, while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree. Although effective in addressing motor dysfunction, long-term use of anti-Parkinsonian agents has been implicated as a component in the development of psychiatric side effects including psychosis. Treatment of psychosis with typical antipsychotics is not recommended in this patient population, since even low potency typical antipsychotics can cause marked exacerbations of parkinsonism in Parkinson's disease patients. The use of atypical antipsychotics (e.g., clozapine, risperidone and quetiapine) has shown some efficacy in the treatment of psychosis in PD patients. Melperone is classified atypical antipsychotic. European experience with melperone spans more than 30 years, and it encompasses an established antipsychotic efficacy profile in the treatment of confusion, anxiety, unrest (particularly in the elderly) and schizophrenia as well as a favorable safety and tolerability profile. Eligible subjects with Parkinson's disease psychosis will participate in a 1-2 week Screening/Washout Period, a 5 week Titration Phase (one of three doses of melperone or placebo), a 1 week Maintenance Phase and a Taper/Follow-up Period up to 2 weeks. Following the Day 43 assessment, subjects may be given the option of receiving melperone in an open-label extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
20 mg/day. Strength of melperone syrup is 5 mg/mL
40 mg/day. Strength of melperone syrup is 5 mg/mL
60 mg/day. Strength of melperone syrup is 5 mg/mL
Northwest Neurospecialists, PLLC
Tucson, Arizona, United States
Patient Evaluation of Symptoms of Psychosis.
The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.
Time frame: 6 weeks (from Baseline to end of Maintenance Period)
Investigator/Caregiver Evaluations of Motor Function
The change in the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.
Time frame: 6 weeks (from Baseline to end of Maintenance Period)
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Syrup formulation
Bradenton Research Center, Inc
Bradenton, Florida, United States
University of South Florida
Tampa, Florida, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Struthers Parkinson's Center, Park Nicollet Health Services
Golden Valley, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Neurology Consultants of the Carolinas
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Neurology Associates
San Antonio, Texas, United States
...and 11 more locations