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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


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.

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