Evidence map›Paper›PMID 34496081›Full record

ArticleMovement disorders : official journal of the Movement Disorder Society2021

Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study.

Werner Poewe, Fabrizio Stocchi, David Arkadir, Georg Ebersbach, Aaron L Ellenbogen, Nir Giladi, Stuart H Isaacson, Karl Kieburtz, Peter LeWitt, C Warren Olanow and 12 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Movement disorders : official journal of the Movement Disorder Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02726386 (A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02726386 phase2active not recruitingnot on this map

A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

TypeinterventionalSponsorNeuroDerm Ltd.Ran2016 to 2027Enrolled214ConditionsParkinson's DiseaseArmsND0612
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of continuous subcutaneous ND0612 Infusion compared to oral and alternative regimens in managing motor fluctuations in Parkinson's disease: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Device aided therapies in Parkinson disease: an expert view on apomorphine.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  7. Observational
  8. Review
  9. Review
  10. Clinicians' viewpoints on current paradigms of care and research in Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  11. Review
  12. Article
  13. Article
  14. Current and novel infusion therapies for patients with Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2023
    Review
  15. Review
  16. Parkinson's disease therapy: what lies ahead?Journal of neural transmission (Vienna, Austria : 1996) · 2023
    Review
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 12 institutions in 5 countries.

Werner PoeweDepartment of Neurology, Medical University Innsbruck, Innsbruck, Austria.
Fabrizio StocchiUniversity and Institute for Research and Medical Care IRCCS San Raffaele, Rome, Italy.
David ArkadirDepartment of Neurology, The Faculty of Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Georg EbersbachMovement Disorder Clinic, Beelitz-Heilstaetten, Beelitz, Germany.
Aaron L EllenbogenMichigan Institute for Neurological Disorders, Farmington Hills, Michigan, USA.
Nir GiladiTel Aviv Medical Center, Sackler School of Medicine, Sagol School of Neurosciences, Neurological Institute, Tel-Aviv University, Tel Aviv, Israel.
Stuart H IsaacsonParkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA.
Karl KieburtzDepartments of Neurology, Wayne State University School of Medicine and Henry Ford Hospital, Detroit, Michigan, USA.
Peter LeWittClintrex Research Corp, Sarasota, Florida, USA.
C Warren OlanowDepartments of Neurology, Wayne State University School of Medicine and Henry Ford Hospital, Detroit, Michigan, USA.ORCID 0000-0001-5471-1471
Tanya SimuniNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Astrid ThomasDepartment of Neuroscience, Imaging and Clinical Sciences and Center of Advanced Studies and Technology CAST, University Chieti Pescara, Chieti, Italy.
Abraham ZlotogorskiDepartment of Dermatology, The Faculty of Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Liat AdarNeuroDerm Ltd, Rehovot, Israel.
Ryan CaseNeuroDerm Ltd, Rehovot, Israel.ORCID 0000-0002-5922-2041
Sheila OrenNeuroDerm Ltd, Rehovot, Israel.
Shir Fuchs OrenbachNeuroDerm Ltd, Rehovot, Israel.
Olivia RosenfeldNeuroDerm Ltd, Rehovot, Israel.
Nissim SassonNeuroDerm Ltd, Rehovot, Israel.
Tami YardeniNeuroDerm Ltd, Rehovot, Israel.
Alberto J EspayJames J. and Joan A. Gardner Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio, USA.ORCID 0000-0002-3389-136X
BeyoND study group
NeuroDerm (Israel) · ILHebrew University of Jerusalem · ILWayne State University · USInnsbruck Medical University · ATMichigan Institute for Neurological Disorders · USNeurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson · DENorthwestern University · USParkinson's Research and Education Foundation · USTel Aviv University · ILUniversity of Chieti-Pescara · ITUniversity of Cincinnati · USVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundContinuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations.

objectiveEvaluate 1-year safety data.

methodsBeyoND is an open-label study evaluating the long-term safety of two ND0612 dosing regimens.

resultsOf the 214 enrolled patients (24-hour SC infusion: n = 90; 16-hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants.

conclusionsSubcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

LevodopaParkinson DiseaseAntiparkinson AgentsCarbidopaDrug CombinationsGelsHumansAntiparkinson AgentsCarbidopaDrug CombinationsGelsLevodopainfusionlevodopasafetysubcutaneous

Identifiers

PMID34496081
PMCPMC9291977
OpenAlexW3198835449

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.