Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

Phase 3 Completed 427 enrolled Bial - Portela C S.A.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2011-03
Primary completion: 2012-07
Completion: 2012-07

Outcome

Met primary endpoint

paper The adjusted treatment difference vs placebo was significant for the 50-mg/d opicapone group (treatment effect, -54.3 [95% CI, -96.2 to -12.4] minutes; P = .008), PMID 28027332 ↗

Publications

Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Opicapone	Small molecule	25 mg	—
Subject	Opicapone	Small molecule	50 mg	—
Background	Carbidopa	Unknown	—	—
Background	Levodopa	Unknown	—	—
Background	benserazide	Small molecule	—	—