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Abstract Details

Efficacy and Safety of Continuous Subcutaneous ND0612 Infusion Compared with Oral Immediate-release Levodopa-Carbidopa in Patients with Parkinson’s Disease and Motor Fluctuations
Movement Disorders
ES1 - Emerging Science 1 (11:21 AM-11:27 AM)
002

ND0612 is an investigational, continuous 24-hours/day subcutaneous infusion of levodopa/carbidopa.

Determine the efficacy, safety, and tolerability of ND0612 versus oral immediate-release levodopa/carbidopa (IR-LD/CD) in patients with Parkinson’s disease (PwP) experiencing motor fluctuations.

Double-blind, double-dummy (DBDD), parallel-group clinical trial (NCT04006210). PwP on ≥4 oral LD/CD doses/day (≥400mg/day LD) and experiencing ≥2.5h of daily OFF-time underwent 4-6 weeks of open-label IR-LD/CD dose adjustment followed by 4-6 weeks of open-label ND0612 conversion with adjunctive oral IR-LD/CD as needed to optimize ND0612 regimens. Patients were then randomized (1:1) to 12-week DBDD treatment with either their optimized ND0612 or IR-LD/CD regimens. Primary efficacy endpoint was the change in ON-time without troublesome dyskinesia from self-report diaries.

Baseline characteristics of the 259 patients were balanced between groups. In the DBDD, the ND0612 regimen provided an additional 1.72h [1.08h, 2.36h] of ON-time without troublesome dyskinesia compared to IR-LD/CD (p<0.0001). Mean ON-time without troublesome dyskinesia increased in both arms while on ND0612 during conversion from 9.4h (both arms) at enrollment to 11.8h (ND0612) and 12.1h (IR-LD/CD). During the 12-week DBDD treatment, ON-time without troublesome dyskinesia was maintained in the ND0612 group (11.5h at endpoint) but decreased in the IR-LD/CD group (9.9h at endpoint). Significant treatment effects were also seen in the first four hierarchical secondary endpoints: OFF-time, MDS-UPDRS Part II, and global impressions by patients and clinicians (all p<0.0001). Infusion site reactions were the most reported adverse events (83.8% during conversion, DBDD: 57.0% for ND0612, 42.7% for IR-LD/CD). Discontinuation rates overall and due to adverse events in DBDD were 6.3% and 5.5% for the ND0612 group and 6.1% and 3.1% for the IR-LD/CD groups.

In this study, treatment with ND0612 led to significant, clinically meaningful improvement in motor fluctuations and functional endpoints such as improved experiences of daily living vs oral IR-LD/CD and was well tolerated.

Authors/Disclosures
Alberto J. Espay, MD, FAAN (University of Cincinnati)
PRESENTER
Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus (formerly, USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avion Pharmaceuticals. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Alberto Albanese, MD (Universita Cattolica Sacro Cuore) Dr. Albanese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen pharma. Dr. Albanese has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz pharms. Dr. Albanese has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Publishing Group. Dr. Albanese has a non-compensated relationship as a President with International Association on Parkinsonism and Related Disorders that is relevant to AAN interests or activities.
Aaron Ellenbogen, DO Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
Joaquim J. Ferreira No disclosure on file
Nir Giladi, MD, FAAN (Tel-Aviv Medical Center) Dr. Giladi has received personal compensation in the range of $0-$499 for serving as a Consultant for Sionara. Dr. Giladi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDerm. Dr. Giladi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pharma2B. Dr. Giladi has stock in Vibrant. Dr. Giladi has stock in Lysosomal Therapeutics . The institution of Dr. Giladi has received research support from The Michael J Fox Foundation. The institution of Dr. Giladi has received research support from The National Parkinson Foundation. The institution of Dr. Giladi has received research support from The European Union . The institution of Dr. Giladi has received research support from The Israel Science Foundation. The institution of Dr. Giladi has received research support from Biogen . The institution of Dr. Giladi has received research support from Ionis. The institution of Dr. Giladi has received research support from Sieratzki Family Foundation . The institution of Dr. Giladi has received research support from The Aufzien Academic Center in Tel-Aviv University.
Tanya Gurevich, MD (Tel Aviv Medical Center) Dr. Gurevich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medison, Abbvie, Teva, Neuroderm . Dr. Gurevich has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medison, Abbvie, Teva, Neuroderm, Truemed . Dr. Gurevich has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medison, Acino Ukraine, Abbvie. The institution of Dr. Gurevich has received research support from Parkinson's Disease and Movement disorders society .
No disclosure on file
No disclosure on file
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Karl D. Kieburtz, MD (University of Rochester Medical Center) Dr. Kieburtz has received personal compensation for serving as an employee of Clintrex Research Corporation. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Kieburtz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Kieburtz has stock in Clintrex Research Corp. Dr. Kieburtz has stock in Hoover Brown. An immediate family member of Dr. Kieburtz has stock in Hoover Brown. Dr. Kieburtz has stock in Safe Therapeutics. The institution of Dr. Kieburtz has received research support from NIH. The institution of Dr. Kieburtz has received research support from Michae J Fox Foundation.
Peter A. LeWitt, MD (Henry Ford Hospital - Franklin Pointe) Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda Therapeutics. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for US WorldMeds LLC. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin Inc. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe-NeuroDerm Neuropharma. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bukwang Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. LeWitt has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for CLINICAL NEUROPHARMACOLOGY.
No disclosure on file
C. W. Olanow, MD Dr. Olanow has received personal compensation for serving as an employee of Clintrex Research Corporation. Dr. Olanow has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Clintrex Research Corporation. Dr. Olanow has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Chevron/Syngenta. Dr. Olanow has stock in Clintrex Research Corporation.
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center) Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allevion. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Photopharmics. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sun Biopharma. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Biohaven. The institution of Dr. Pahwa has received research support from EIP. The institution of Dr. Pahwa has received research support from Amneal. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theranexus. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Voyager. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Annovis. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Praxis. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB.
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.
Harini Sarva, MD, FAAN (Weill Cornell Medical Center) Dr. Sarva has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Sarva has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novo Nordisk. Dr. Sarva has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novo Nordisk. The institution of Dr. Sarva has received research support from Insightec. The institution of Dr. Sarva has received research support from NeuroNext. The institution of Dr. Sarva has received research support from Neuroderm. The institution of Dr. Sarva has received research support from Covance. The institution of Dr. Sarva has received research support from Prevail. The institution of Dr. Sarva has received research support from Bluerock Therapeutics. The institution of Dr. Sarva has received research support from Biogen. The institution of Dr. Sarva has received research support from Roche. The institution of Dr. Sarva has received research support from National Institute of Aging. The institution of Dr. Sarva has received research support from Michael J Fox Foundation. The institution of Dr. Sarva has received research support from Novo Nordisk. Dr. Sarva has received research support from Bukwang. The institution of Dr. Sarva has received research support from Bial.
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.
Tamar Yardeni Tamar Yardeni has received personal compensation for serving as an employee of NeuroDerm.
Liat Adar (Neuroderm) Liat Adar has received personal compensation for serving as an employee of Neuroderm.
Laurence Salin Laurence Salin has received personal compensation for serving as an employee of NeuroDerm.
Nelson F. Lopes No disclosure on file
No disclosure on file
Ryan J. Case, PhD Dr. Case has received personal compensation for serving as an employee of NeuroDerm.
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).