drugset / Trial / NCT01568073
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2011-03
- Primary completion
- 2013-11
- Completion
- 2013-11
Outcome
Met primary endpoint
paper Treatment with opicapone 50 mg was superior to placebo (mean difference in change from baseline -60·8 min, 95% CI -97·2 to -24·4; p=0·0015) PMID 26725544 ↗
paper and non-inferior to entacapone (-26·2 min, -63·8 to 11·4; p=0·0051). PMID 26725544 ↗
Publications
- Harrison-Jones G, Green W, Bainbridge J. The Cost-Effectiveness of Opicapone Versus Entacapone as Adjuvant Therapy for Levodopa-Treated Individuals With Parkinson's Disease Experiencing End-of-Dose Motor Fluctuations. Parkinsons Dis. 2025 Sep 11;2025:8408907. doi: 10.1155/padi/8408907. eCollection 2025.
- Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P; Bi-Park 1 investigators. Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol. 2016 Feb;15(2):154-165. doi: 10.1016/S1474-4422(15)00336-1. Epub 2015 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Entacapone | Small molecule | 200 mg | Oral |
| Subject | Opicapone | Small molecule | 5 mg | Oral |
| Subject | Opicapone | Small molecule | 25 mg | Oral |
| Subject | Opicapone | Small molecule | 50 mg | Oral |
| Background | Carbidopa | Unknown | — | — |
| Background | Levodopa | Unknown | — | — |
| Background | benserazide | Small molecule | — | — |