Abstract Details

Title Long-term Follow-up of Opicapone Use as Add-on to Levodopa in Parkinson’s Patients Without Motor Fluctuations: Findings from the EPSILON Study

Topic Movement Disorders

Presentation(s) P7 - Poster Session 7 (5:00 PM-6:00 PM)

Poster/Presentation
Number 5-027

Objective

To assess the long-term effect of opicapone (OPC) in enhancing the clinical benefit of oral Levodopa therapy in Parkinson’s Disease (PD) patients without motor complications.

Background Opicapone is routinely used to optimize levodopa in PD patients with motor complications. The EPSILON study investigated Opicapone’s clinical efficacy in PD patients without motor complications.

Design/Methods This was a randomized, double-blind (DB), placebo-controlled (PLC) study followed by a 1-year open-label (OL) extension. Levodopa-treated PD patients without motor complications were randomized to 24 weeks of DB treatment with adjunct opicapone 50mg or matching placebo. Patients who completed this phase entered a 1-year OL extension where all patients received opicapone 50mg. The primary endpoint was the mean change from DB baseline to week 24 in MDS-UPDRS-III. The mean change from OL baseline to week 52 in MDS-UPDRS-IV was the key endpoint for the OL extension.

Results At week 24, OPC significantly improved MDS UPDRS-Part III score compared to PLC (mean difference [Standard deviation (SD)] of -2.2(0.9)). Patients who remained on opicapone (OPC-OPC, n=121) had sustained motor improvement of -0.6(8.79) over the 1-year OL period, with negligible daily levodopa adjustments. Patients switching from placebo to opicapone (PLC-OPC, n=129), showed a mean -2.1(7.9) improvement, consistent with the treatment effects of OPC in the DB period. The PLC-OPC group had a slightly lower magnitude of effect over time compared to the OPC-OPC group, with a least squared mean treatment difference of 1.3 (95% CI: -3.3, 0.7; p=0.196) at the end of OL period. Fewer OPC-OPC patients reported motor complications (MDS-UPDRS Part IV total score ≥1) compared to the PLC-OPC group (11.6% vs. 16.3%, p=ns), with a mean score of 0.3 for both groups.

Conclusions This data supports persistent beneficial motor effects over 12 months without increasing dyskinesia risk following the addition of opicapone to levodopa in PD subjects without motor fluctuations.

Authors/Disclosures
Joaquim J. Ferreira PRESENTER	The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bial, Neurocrine, AbbVie, Biogen and Lundbeck. The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurocrine, AbbVie, BIAL, Biogen, Lundbeck . The institution of Joaquim J. Ferreira has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, BIAL, Nordic Infucare, ONO and SK Chemicals.
Olivier Rascol, MD, PhD (Departments of Clinical Pharmacology and Neurosciences-CIC9302/INSERM 825)	Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie, Acorda, Aguettant, Alkahest, AlzProtect, Apopharma, Astrazeneca, Axovant, Bial, Biogen, Britannia, Buckwang, Centogene, Cerevel, Clevexel, Contera, GE Healthcare, Handltherapeutic, Ionis, Irlab, Jazz, Kyowa, LGD Nuvamid, Lundbeck, Merck, Merz, MundiPharma, Neuralight, Neuratris, Neuroderm, Novartis, ONO Pharma, Orion Pharma, Osmotica, Oxford Biomedica, Parexel, PD Neurotechnology, Pfizer, Polycaps, Prexton, Roche Therapeutics, Sanofi, Scienture, Servier,Sombiotech, Sunovion, Supernus, Synagile, Thelonius Mind, Takeda, Théranexus, Teva, Tools4patient, UCB, Vision 2 voice, XenoPort, XO, Zambon . Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie, Acorda, Aguettant, Alkahest, AlzProtect, Apopharma, Astrazeneca, Axovant, Bial, Biogen, Britannia, Buckwang, Centogene, Cerevel, Clevexel, Contera, GE Healthcare, Handltherapeutic, Ionis, Irlab, Jazz, Kyowa, LGD Nuvamid, Lundbeck, Merck, Merz, MundiPharma, Neuralight, Neuratris, Neuroderm, Novartis, ONO Pharma, Orion Pharma, Osmotica, Oxford Biomedica, Parexel, PD Neurotechnology, Pfizer, Polycaps, Prexton, Roche Therapeutics, Sanofi, Scienture, Servier,Sombiotech, Sunovion, Supernus, Synagile, Thelonius Mind, Takeda, Théranexus, Teva, Tools4patient, UCB, Vision 2 voice, XenoPort, XO, Zambon . Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIAL. Dr. Rascol has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MEDIZIN ACADEMY. The institution of Dr. Rascol has received research support from Agence Nationale de la Recherche (ANR), CHU de Toulouse, France-Parkinson, INSERM-DHOS Recherche Clinique Translationnelle, MJFox Foundation, Programme Hospitalier de Recherche Clinique, European Commission (FP7, H2020).
Fabrizio Stocchi	Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial, Biogen, Sunovion, Lundbeck, UCB, Zambon, Chiesi, Lusofarmaco, Abbvie, Neuroderm, Kyowa, Synegile, Roche, Britannia, Sunovion, Blue Rock. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL, Zambon, Biogen, Roche, Synegile, Sunovion. Fabrizio Stocchi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bial, Zambon, UCB, Kyowa, Sunovion.
Angelo Antonini, MD	Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIAL. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Antonini has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for THERAVANCE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ROCHE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ABBVIE. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ZAMBON. Dr. Antonini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BOEHRINGER.
Paloma Lapuente, MD	Mrs. Lapuente has received personal compensation for serving as an employee of BIAL .
Guillermo Castilla-Fernandez, MD	Mr. Castilla-Fernandez has nothing to disclose.
Helena Brigas, PhD	Dr. Brigas has received personal compensation for serving as an employee of BIAL.
Ghazal Banisadr, PhD (Amneal Pharmaceuticals)	Dr. Banisadr has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Francisco Rocha	Francisco Rocha has received personal compensation for serving as an employee of BIAL - Portela.
Joerg Holenz, PhD	Mr. Holenz has received personal compensation for serving as an employee of BIAL. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAL RD Investments. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAl Portela SA. Mr. Holenz has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for BIAL Biotech . Mr. Holenz has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. Mr. Holenz has stock in Astra Zeneca. Mr. Holenz has received intellectual property interests from a discovery or technology relating to health care.
Werner Poewe, MD (University Hospital of Neurology)	Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Affiris . Werner Poewe, MD has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alterity, AbbVie, BIAL, Biogen, Britannia, Lilly, Lundbeck, Neuroderm, Neurocrine, Denali Pharmaceuticals, ,Roche, Takeda, UCB and Zambon . Werner Poewe, MD has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, Britannia, BIAL, STADA, Lundbeck, Zambon. The institution of Werner Poewe, MD has received research support from MJFF; EU Horizon programme. Werner Poewe, MD has a non-compensated relationship as a Committee member with Movement Disorder Society that is relevant to AAN interests or activities.

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