Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005

• Conditions: Psycosis associated to Parkinson's Disease; MedDRA version: 9.1Level: HLTClassification code 10027361Term: Mental disorders due to a general medical condition NEC

• Registration Number: EUCTR2007-002874-75-IT
• Lead Sponsor: OVATION PHARMACEUTICALS INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified