Phase 3
N=427
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01227655 ↗Enrolled (actual)
427
Serious AEs
4.4%
Results posted
Jan 2015
Primary outcome: Primary: Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor) — -102.8; -124.0; -64.5 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BIA 9-1067 (Drug); Placebo (Drug); Levodopa (Drug); Carbidopa (Drug); Benserazide (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor) |
-102.8; -124.0; -64.5 | — |
| SECONDARY UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON) |
30.8; 31.7; 31.5; 26.6; 28.7; 28.1 | — |
| SECONDARY Parkinson's Disease Sleep Scale (PDSS) |
95.75; 102.62; 101.76; 97.99; 103.05; 107.11 | — |
| SECONDARY Non-motor Symptoms Scale (NMSS) |
38.2; 36.7; 38.2; 33.7; 33.2; 33.5 | — |
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
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01227655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.