At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 82 enrolled
Drug / intervention
BIA 9-1067 5 mg +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.
A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating BIA 9-1067 5 mg, Entacapone, and 4 other interventions for Parkinson Disease. Completed, enrolled 82 participants across 1 site.
Detailed Summary
To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesPortugal
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
Primary CompletionFeb 2010
Study CompletionJun 2011
First PostedJan 2012
TodayJul 2026
First PostedJan 26, 2012
Enrollment StartNov 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.4 years ago
Interventions
BIA 9-1067 5 mgdrug
BIA 9-1067 OPC, Opicapone 5 mg
Entacaponedrug
Entacapone 200 mg
Placebodrug
placebo (four times a day)
levodopa/carbidopadrug
standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 15 mgdrug
BIA 9-1067 OPC, Opicapone 15 mg
BIA 9-1067 30 mgdrug
BIA 9-1067 OPC, Opicapone 30 mg