At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of idiopathic Parkinson's Disease with at least three cardinal features (rest tremor, rigidity, bradykinesia/akinesia, or postural/gait abnormalities)
- ✓Active visual and/or auditory hallucinations with or without delusions in the 4 weeks before screening, severe enough to warrant antipsychotic treatment
- ✓Neuropsychiatric Inventory (NPI) Hallucinations or Delusions score >4 at screening or re-screening
- ✓Stable dose of anti-Parkinsonian medications for ≥7 days or 5 half-lives (whichever is longer) prior to screening
- ✕History of significant psychotic disorder prior to PD diagnosis (schizophrenia, bipolar disorder)
- ✕Dementia with Lewy Bodies (DLB)
- ✕Dementia or major depressive disorder precluding accurate assessment on rating scales
- ✕Acute depressive episode at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating Melperone HCl and Placebo for Parkinson's Disease and Psychotic Disorders. Completed, enrolled 90 participants across 21 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
Syrup formulation