advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Sponsors
Solvay Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have signed informed consent for participation in the safety extension study. 2. Subjects who have completed the S308.3.004 trial. 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: Subjects with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (Visit M3, Week 12 of maintenance) of study S308.3.004.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect and evaluate long-term safety and tolerability data of pardoprunox (SLV308) treatment in patients with Parkinson’s disease (PD) experiencing motor fluctuations.;Secondary Objective: – To collect descriptive efficacy data with respect to ON and OFF-time and dyskinesia as recorded by subject home diaries. – To collect descriptive efficacy data with respect to the motor functioning of PD subjects and overall PD symptoms, including Activities of Daily Living (ADL) and Clinical Global Impression (CGI) after long-term treatment with pardoprunox (SLV308) in the dose range of 6 42 mg/day. – To investigate the effects of long-term pardoprunox (SLV308) treatment on quality of life by assessing the Parkinson’s Disease Questionnaire (PDQ-39) and Euroqol 5-item questionnaire (EQ-5D). – To collect and evaluate Health Economic parameters by the Caregiver Burden Inventory (CBI) and Caregiver’s Assistance in Activities of Daily Living (CAADL). – To collect and evaluate data on population pharmacokinetics of pardoprunox (SLV308).;Primary end point(s): Efficacy: ON/OFF/dyskinesia symptom recording in patient home diary, UPDRS (Parts 1 to 4), CGI Severity (CGI-S), CGI Improvement (CGI-I), Parkinson’s Disease Questionnaire (PDQ 39) and Euroqol 5-item questionnaire (EQ-5D), Schwab and England activities of daily living (ADL) (UPDRS Part 6), modified Hoehn and Yahr (UPDRS Part 5), Caregiver Burden Inventory (CBI) and Caregiver’s Assistance in Activities of Daily Living (CAADL). Pharmacokinetics:Data obtained on population pharmacokinetics of pardoprunox (SLV308). Safety:Adverse events (AEs), concomitant medications, vital signs, physical examination, electrocardiogram (ECG) and laboratory assessments. | — |
Countries
Hungary
Outcome results
None listed