At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
BIA 9-1067 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations ("Wearing-off" Phenomenon)
In Brief
A Phase 2 clinical trial evaluating Placebo, BIA 9-1067, and 2 other interventions for Parkinson's Disease. Completed, enrolled 40 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesRomania, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
Primary CompletionJun 2010
First PostedApr 2012
TodayJul 2026
First PostedApr 2, 2012
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago
Interventions
Placebodrug
once-daily
BIA 9-1067drug
BIA 9-1067 - 5 mg single-dose
BIA 9-1067drug
BIA 9-1067 - 15 mg single-dose
BIA 9-1067drug
BIA 9-1067 - 30 mg single-dose
Levodopa/Carbidopadrug
Levodopa 100 mg Carbidopa 25 mg
Levodopa/Benzerazidedrug
Levodopa 100 mg Benzerazide 25 mg