Health Condition 1: null- Parkinsons Disease
Conditions
Interventions
Intervention1: BIA 9-1067: 25 mg once daily (QD) orally up to 71 weeks
Intervention2: BIA 9-1067: 50 mg once daily (QD) orally up to 71 weeks
Control Intervention1: Placebo: Once daily orally up to 15
Sponsors
BIAL Portela Ca SA
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to comprehend and willing to sign an informed consent form. 2. Male and female subjects between 30 and 83 years old, inclusive. 3. Diagnosed with idiopathic PD according to the UK Parkinsons Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDSBBCDC) for at least 3 years. 4. Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON. 5. Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement. 6. Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation. 7. On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening. 8. Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigators judgment.
Exclusion criteria
Exclusion criteria: 1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome). 2. Dyskinesia disability score 3 in the Unified Parkinsons Disease Rating Scale UPDRS) Sub-section IV A, item 33. 3. Severe and/or unpredictable OFF periods. 4. Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening. 5. Treatment with apomorphine within the month before screening or likely to be needed at any time during the study. 6. Dosage change of concomitant anti-PD medication within 4 weeks of screening. 7. Previous or planned (during the entire study duration, including the OL period)deep brain stimulation. 8. Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period. 9. Any investigational medicinal product (IMP) within the 3 months (or within 5 half-lives, whichever is longer) before screening. 10. Any medical condition that might place the subject at increased risk or interfere with assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg), administered once a day, compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.Timepoint: 14-15 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-motor Symptoms Scale (NMSS)Timepoint: 14-15 weeks;Parkinsons Disease Sleep Scale (PDSS)Timepoint: 14-15 weeks;UPDRS Sections I (ON), II (ON and OFF), and III (ON) Timepoint: 14-15 weeks | — |
Countries
Argentina, Australia, Belgium, Chile, Czech Republic, Estonia, India, Israel, Other, Russian Federation, South Africa, United Kingdom
Contacts
Public ContactSuchela Srivatsa
Quintiles Research India Pvt. Ltd.
Outcome results
None listed