Status:
COMPLETED
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-83 years
Phase:
PHASE3
Brief Summary
Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year. BIA 9-1067 is currently being developed by BIAL (Portela \& C...
Detailed Description
This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD. DDCI (DOPA decarboxylase inhibitors):...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an informed consent form.
- Male and female subjects between 30 and 83 years old, inclusive.
- Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
- Disease severity Stages I-III (modified Hoehn \&Yahr staging) at ON.
- Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
- Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
- On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
- 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 investigator's judgment.
Exclusion
- Non-idiopathic PD (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome).
- Dyskinesia disability score \>3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
- Severe and/or unpredictable OFF periods.
- 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.
- Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
- Dosage change of concomitant anti-PD medication within 4 weeks of screening.
- Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
- Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
- Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
- Any medical condition that might place the subject at increased risk or interfere with assessments.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT01227655
Start Date
March 1 2011
End Date
July 1 2012
Last Update
October 19 2015
Active Locations (1)
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1
Bial - Portela & Cª, S.A.
S. Mamede Do Coronado, Portugal, 4745-457