Psycosis associated to Parkinson's Disease MedDRA version: 9.1 Level: HLT Classification code 10027361 Term: Mental disorders due to a general medical condition NEC
Conditions
Interventions
Product Name: Melperon
Pharmaceutical Form: Syrup
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
OVATION PHARMACEUTICALS INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients and/or their legally authorised representative (LAR) must have signed and dated the Informed Consent Form approved by the Ethics Committee of the structure where they are cured; 2. Participation in the previous Ovation sponsored study on the psychosis of Parkinson?s Disease with melperone. 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: 1. Patients remaining more than 14 days without treatment from when the last dose of the experimental medication was taken in the previous Ovation sponsored study on psychosis in PD; 2. Patients having serious or severe adverse effects in the previous Ovation sponsored study on psychosis in PD which, in the opinion of the Investigator, was probably or certainly connected to the use of the melperone; 3. History of serious cardiovascular conditions (including, for simplicity but not limited to, class IV angina or class IV heart failure) and/or of risk factors for Torsade de pointes (Tdp) (including for simplicity but not limited to, current treatment for hypokalemia or family history of long QT syndrome); 4. During the previous Ovation sponsored study on psychosis in PD, the patient had an ECG with a corrected QT interval with the Bazett formula, of more than 450 msec if female, 430 msec if male. If the patient had an ECG greater than 450 msec if female, or 430 if male, then he/she may take part in the new study as long as: a. the patient did not have a value of QTc greater than 500 msec during the double-blind study; b. the patient's QTc was ≤450 msec if female, or ≤430 msec if male, at Day 43 (for patients under treatment with 4 ml of experimental drug) or at the Final Visit of the double-blind study. i. Patients who have had a QTc >450 msec if female, or >430 msec if male at Day 43 or at the Final Visit may be eligible in the new study if they gradually reduce the dose of the drug to 0 ml, return to repeat the ECG and this new ECG shows a QTc ≤450 msec if female, or ≤430 msec if male. 5. Patients requiring therapy with an alpha-agonist agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and effectiveness of melperone in open-label studies in treating patients with psychosis associated with Parkinson?s Disease;Secondary Objective: ;Primary end point(s): Assessment of effectiveness The primary effectiveness endpoint will be the change in the SAPS score. Other effectiveness endpoints may be other neuropsychiatric scales, like the NPI total score and relevant items and subscales, and UPDRS and relevant subscales. Safety Safety assessments include the analysis of adverse events, serious adverse events, physical examination, calculation of the Body Mass Index (BMI), laboratory test values, vital signs and ECG intervals. | — |
Countries
Italy
Outcome results
None listed