Psicosi associata al morbo di Parkinson MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Product Name: Melperon
Pharmaceutical Form: Syrup
INN or Proposed INN: melperon
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form
Sponsors
OVATION PHARMACEUTICALS INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and efficacy of 20, 40, and 60 mg per day of melperone syrup (5 mg/ml) in subjects with psychosis associated to Parkinson’s Disease. ;Secondary Objective: ;Primary end point(s): | — |
Countries
Italy
Outcome results
None listed