Article Text

Download PDFPDF

141 Switching from double-blind entacapone or placebo to open-label opicapone: NMSS results (1-year extension BIPARK-I study)
  1. O Fabregues1,
  2. E Tolosa2,
  3. J Ferreira3,
  4. A Lees4,
  5. A Santos5,
  6. J Rocha6,
  7. P Soares-Da-Silva5
  1. 1University Hospital of Vall d’Hebron, Barcelona/Spain
  2. 2Hospital Clinic Universitari de Barcelona, Barcelona/Spain
  3. 3Instituto de Medicina Molecular, Neurological Clinical Research Unit, Lisbon/Portugal
  4. 4National Hospital for Neurology and Neurosurgery, London
  5. 5BIAL-Portela and Co S.A., Global Parkinson Disease, S. Mamede Coronado/Portugal
  6. 6BIAL-Portela and Co S.A., Research and Development, S. Mamede Coronado/Portugal

Abstract

Background Opicapone (OPC), a novel once-daily peripheral COMT inhibitor, has shown to be safe and effective in reducing OFF-time in Parkinson’s disease (PD) patients with motor fluctuations.

Objective To evaluate impact on non-motor symptoms in levodopa-treated PD patients who switched from placebo (PLC) or entacapone (ENT) to OPC in the BIPARK-I open-label extension (OLE).

Methods BIPARK-I, a multinational, multicentre, double-blind, 14–15-week, PLC and active-controlled study evaluated the efficacy of OPC 5 mg, 25 mg or 50 mg in PD patients with end-of-dose motor fluctuations. ENT was included as a reference arm.

Following the double-blind BIPARK-I study, all eligible patients were switched to OPC 25 mg once-daily in a 1-year OLE regardless of prior double-blind treatment. After one week either OPC or levodopa could be adjusted according to response.

This post-hoc analysis investigated impact on Non-Motor Symptoms Scale (NMSS) score in PLC and ENT ‘switchers’.

Results Following the one-year OLE, NMSS changes (least-square mean [95%CI]) from DB baseline were -5.7, -4.7 and -2.0 and from OL baseline were -3.8, -0.2 and -0.4 for PLC, ENT and OPC 50 mg, respectively.

Conclusion No worsening NMSS score for subjects switching from double-blind ENT. PLC-switched subjects from DB to end of 1 year open-label OPC presented significantly less disability.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.