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142 Influence of baseline OFF-time on opicapone efficacy in Parkinson’s disease patients with motor fluctuations
  1. P Korlipara1,
  2. J Ferreira2,
  3. H Gama3,
  4. A Santos3,
  5. F Ikedo3,
  6. J Rocha4,
  7. P Soares-Da-Silva3
  1. 1National Hospital for Neurology and Neurosurgery, University College Hospital, Queen Square, London
  2. 2Neurological Clinical Research Unit, Instituto de Medicina Molecular, Lisbon, Portugal
  3. 3BIAL – Portela and Co S.A., Research and Development, S. Mamede Coronado/Portugal
  4. 4BIAL – Portela and Co S.A., Global Parkinson Disease, 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 the efficacy of OPC in levodopa-treated PD patients with motor fluctuations and subdivided by their baseline OFF-time.

Methods BIPARK-I was a multinational, multicentre, double-blind, 14–15-week, placebo and active-controlled study to evaluate the efficacy of OPC in PD patients with end-of-dose motor fluctuations. This post-hoc subgroup analysis investigated efficacy of OPC 50 mg and entacapone (ENT), in levodopa-treated PD patients who were subdivided by baseline OFF-time (>90 mins and every additional 30 mins interval up to an interval with minimum sample size of 40 patients per active arm).

Results Subjects with higher baseline OFF-times had a greater response under both OPC 50 mg and ENT with an average difference of -26.6 mins OFF-time reduction favouring OPC 50 mg. The estimated difference increased with increasing baseline OFF-time, reaching statistically significance (p<0.05) for subjects with >390 mins baseline OFF-time.

Conclusion Higher baseline OFF-time correlated with greater response for both OPC 50 mg and ENT. OPC 50 mg presented a greater OFF-time reduction than ENT for all subgroup intervals, reaching statistically significance for subjects with >390 mins baseline OFF-time.

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