At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
BIA 9-1067 +5 moredrug
Likely dose
BIA 9-1067 25 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-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor
In Brief
A Phase 2 clinical trial evaluating BIA 9-1067, Placebo, and 2 other interventions for Parkinson's Disease. Completed, enrolled 10 participants across 3 sites in 3 countries.
Detailed Summary
The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesPortugal, Romania, Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
Primary CompletionFeb 2010
First PostedApr 2012
TodayJul 2026
First PostedApr 2, 2012
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.3 years ago
Interventions
BIA 9-1067drug
BIA 9-1067 - 25 mg single-dose
BIA 9-1067drug
BIA 9-1067 - 50 mg single-dose
BIA 9-1067drug
BIA 9-1067 - 100 mg single-dose
Placebodrug
single-dose
Levodopa/Carbidopadrug
Levodopa 100 mg Carbidopa 25 mg
Levodopa/Benzerazidedrug
Levodopa 100 mg Benzerazide 25 mg