Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Volunteers
Inclusion criteria
The subject or subject's legally authorized representative (LAR) must sign and date the IRB/IEC approved Informed Consent Form and HIPAA Authorization (applicable to US sites only) prior to study participation.
Male or female subjects. If female:
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:
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 total item score (frequency x severity) of > 4 on the Neuropsychiatric Inventory (NPI).
Subject is on a stable dose of anti-Parkinsonian medication(s) for at least 7 days or 5 half-lives, whichever is longer, prior to the screening visit and is expected to remain on a stable dose for the duration of the study.
Subject is willing and able to comply with all study procedures.
Exclusion criteria
Randomization Criteria
Primary purpose
Allocation
Interventional model
Masking
90 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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