None listed
Conditions
Interventions
Phase of Adjustment of Dose: SLV308 will be administered, in capsules, PO, QD, until reaching a dose of 12 mg / day. From this point on, the treatment will be open label and the dose may be increased between 12 to 42 mg / day, until reaching a stable dose. This phase will last 3 weeks. Maintenance Phase: The frequency and doses reached in the Dose Adjustment Phase will be continued for 24 weeks.
Sponsors
SOLVAY PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who sign the informed consent to participate in the extension study. 2. Subjects who have completed study S308.3.001.
Exclusion criteria
Exclusion criteria: 1. Subjects with abnormal medically relevant findings at the end of the maintenance phase of study S308.3.001.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Complete physical examination of all organs and systems. Criterion 2: Height, weight, pulse and blood pressure will be evaluated. Criterion 3: In a 12-lead electrocardiogram, the heart rate, PR intervals, will be evaluated. QRS, QT and QTc. Criterion 4: Hematology and serum chemistry panels, urine test. Criterion 5: Clinical evaluation of any event that begins during the study treatment period or that already exists before the start of that unique treatment but worsens during treatment. Criterion 6: Identification of all antiparkinsonian medication that was not L-dopa or dopamine agonist, taken by the subject during the study. Measure:Security: 1) Physical examination. 2) Vital signs. 3) Electrocardiogram. 4) Laboratory data. 5) Adverse events. 6) Concomitant medication. Timepoints:Adverse events: Before starting treatment and in week 24 of the maintenance period. Vital signs, ECG, adverse events and concomitant medication: Before starting treatment and in weeks 3, 4, 5, 6 and 7 of the dose adjustment period and in weeks 4, 12 and 24 of the maintenance period. Laboratory: Before starting the treatment and in weeks 12 and 24 of the maintenance week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1, 2 and 3: The Unified Scale of Parkinson s Disease Assessment (UPDRS), in its 3 parts. Criterion 4: The CGI evaluates the general clinical condition of the subject Criterion 5: The Parkinson s Disease Questionnaire (PDQ-39) is a self-administered questionnaire comprising 39 items that encompass eight health domains that the subjects consider to be adversely affected by the disease. Criterion 6: The modified Hoehn and Yahr scale assesses the presence and severity of the signs of the disease. Criterion 7: The Schwab and England test assesses the degree of independence or dependence of the patient. Criterion 8: Patient s diary. Measure:Efficacy: 1) UPDRS score, part 3. 2) UPDRS score, part 2. 3) UPDRS score. part 1. 4) Clinical Impression Global-Improvement (CGI-I). 5) Total score of the PDQ-39 and the eight sub-points. 6) Hoehn and Yahr scale modified. 7) Test of Schwab and England. 8) Time until the beginning of the use of L-dopa as a concomitant medication. Timepoints:UPDRS and use of L-dopa: Before starting treatment and in weeks 3, 4, 5, 6 and 7 of the dose adjustment period and in weeks 4, 12 and 24 of the maintenance period. CGI, PDQ-39, Schwab and England: Before starting treatment and in weeks 12 and 24 of the maintenance period. Hoehn and Yahr: Before starting the treatment and in week 24 of the maintenance period. | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Chile, Colombia, Finland, Israel, Italy, Mexico, New Zealand, Peru, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States
Outcome results
None listed