CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
BIA 9-1067 +5 moredrug
Likely dose
BIA 9-1067 50 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.

Search/NCT01568073
NCT01568073Phase 3Completed
CompareCT.gov

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study

Bial - Portela C S.A.·interventional·Posted Apr 2, 2012·Updated Sep 18, 2015

In Brief

A Phase 3 clinical trial evaluating BIA 9-1067, Entacapone, and 4 other interventions for Parkinson's Disease. Completed, enrolled 600 participants across 1 site.

Detailed Summary

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesPortugal
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.3 years ago

Interventions

BIA 9-1067drug

5, 25 and 50 mg of BIA 9-1067 (once-daily)

Entacaponedrug

200 mg entacapone (concomitantly with each L-dopa/DDCI dose)

Placebodrug

200 mg

Levodopadrug

Carbidopadrug

DOPA decarboxylase inhibitor

Benserazidedrug

DOPA decarboxylase inhibitor