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Clinical Trial
. 2019 Jul;26(7):953-960.
doi: 10.1111/ene.13914. Epub 2019 Mar 25.

Long-term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open-label extensions

J J Ferreira  1   2 , A Lees  3 , J-F Rocha  4 , W Poewe  5 , O Rascol  6 , P Soares-da-Silva  4   7   8
Affiliations
Clinical Trial

Long-term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open-label extensions

J J Ferreira et al. Eur J Neurol. 2019 Jul.

Abstract

Background and purpose: The aim was to evaluate the efficacy of the catechol-O-methyltransferase inhibitor opicapone (25 and 50 mg) as adjunct therapy to levodopa in a pooled population of Parkinson's disease patients who participated in the pivotal double-blind trials of opicapone and their 1-year open-label extensions.

Methods: Data (placebo, opicapone 25 mg and opicapone 50 mg) from the BIPARK-1 and BIPARK-2 double-blind and open-label studies were combined. The studies had similar designs, eligibility criteria and assessment methods. The primary efficacy variable in both double-blind studies was the change from baseline in absolute OFF time based on patient diaries.

Results: Double-blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1-6.6 h. The mean (and 95% confidence interval) treatment effect versus placebo was -35.1 (-62.1, -8.2) min (P = 0.0106) for the 25 mg dose and -58.1 (-84.5, -31.7) min (P < 0.0001) for the 50 mg dose. Reductions in OFF time were mirrored by significant increases in ON time without troublesome dyskinesia (P < 0.05 and P < 0.0001 for the 25 and 50 mg doses, respectively). No significant differences were observed for ON time with troublesome dyskinesia. Patient diary results from the open-label phase indicated a maintenance of effect for patients previously treated with opicapone 50 mg. The group previously treated with the 25 mg dose benefitted with further optimization of therapy during the open-label phase, whilst switching from placebo to opicapone led to significant reductions in OFF time and increased ON time.

Conclusions: Over at least 1 year of open-label therapy, opicapone consistently reduced OFF time and increased ON time without increasing the frequency of troublesome dyskinesia.

Keywords: OFF time; Parkinson's disease; motor fluctuations; opicapone.

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Conflict of interest statement

JJF has held consultancy functions with GlaxoSmithKline, Novartis, Teva, Lundbeck, Solvay, Abbott, BIAL, Merck‐Serono, Merz, Ipsen, Biogen; has received lecture fees from Biogen and BIAL; has received grants from GlaxoSmithKline, Grunenthal, MSD, Allergan, Novartis, Fundação MSD (Portugal) and Teva; has been employed by Faculdade de Medicina de Lisboa and CNS – Campus Neurológico Sénior. AL is funded by the Reta Lila Weston Institute of Neurological Studies, University College London, Institute of Neurology and reports consultancies for Britannia Pharmaceuticals, BIAL. He also reports grants and/or research support from the PSP Association, Weston Trust, the Reta Lila Howard Foundation, and honoraria from Britannia, UCB, Roche, Novartis, Boehringer Ingelheim, Lundbeck, GE Healthcare, Teva, GlaxoSmithKline, Ipsen, Allergan, Orion, BIAL, AbbVie, Nordicinfu Care. WP has received consultancy and lecture fees in relation to clinical drug programmes for PD from AbbVie, AstraZeneca, BIAL, Biogen, Britannia, Grünenthal, Intec, Ipsen, Lundbeck, Novartis, Neuroderm, Orion Pharma, Prexton, Roche, Sunovion, Sun Pharma, Takeda, Teva, UCB and Zambon. Royalties: Thieme, Wiley Blackwell, Oxford University Press and Cambridge University Press. OR reports receiving consulting fees from AbbVie, Adamas, Acorda, Addex, AlzProtect, Apopharma, Astrazeneca, Bial, Biogen, Britannia, Clevexel, Cynapsus, INC Research, Lundbeck, Merck, MundiPharma, Neuroderm, Novartis, Osmotica, Oxford Biomedica, Parexel, Pfizer, Prexton Therapeutics, Quintiles, Sanofi, Servier, Takeda, Teva, UCB, XenoPort, Zambon; and grant support from Agence Nationale de la Recherche (ANR), Boehringer Ingelheim, CHU de Toulouse, French Parkinson, GlaxoSmithKline, INSERM‐DHOS, Michael J Fox Foundation, Programme Hospitalier de Recherche Clinique, Recherche Clinique Translationnelle, UCB, Teva and Lundbeck. JFR and PSS are employed by BIAL – Portela & Cª, S.A.

Figures

Figure 1
Figure 1
Patient disposition. The double‐blind safety set includes all patients who took at least one dose of study medication. The full analysis set includes all randomized patients who took one or more doses of study medication and had one or more post‐baseline OFF time assessments. AEs, adverse events; FAS, full analysis set; OPC, opicapone.
Figure 2
Figure 2
Reductions in OFF time. *Change in OFF time for the double‐blind phase was calculated versus the double‐blind baseline (ancova). Change in OFF time for the open‐label phase is described versus the open‐label baseline. ancova, analysis of covariance; MMRM, mixed‐effect model for repeated measurements; OPC, opicapone; TE, treatment estimate [95% confidence interval]. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 3
Figure 3
Clinical Global Impression of Change (double‐blind phase). OPC, opicapone. [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

References

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