Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Placebo; Levodopa; Carbidopa; Benserazide
Intervention description: Capsules will be used.; comparator; DOPA decarboxylase inhibitor (DDCI); DOPA decarboxylase inhibitor
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Benserazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 30 Years
Maximum age: 83 Years
Healthy volunteers: No
Keywords: Parkinson; PD; Wearing-off; Levodopa/DDCI

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 & Cª,S.A.) to be used in addition to
      L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising
      results have been obtained for BIA 9-1067 in previous studies.
    

Eligibility 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 Parkinson's Disease Society Brain
             Bank Clinical Diagnostic Criteria 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 investigator's judgment.

        Exclusion Criteria:

          1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic]
             parkinsonism, Parkinson-plus syndrome).

          2. Dyskinesia disability score >3 in the Unified Parkinson's 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 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.