Evidence map›Paper›PMID 40736131›Full record

Trial reportMovement disorders clinical practice2026

Efficacy and Safety of Foslevodopa/Foscarbidopa Monotherapy in Patients with Parkinson's Disease.

Jason Aldred, Manon Bouchard, Juan Carlos Martínez-Castrillo, Michael J Soileau, Amy M Spiegel, Lars Bergmann, Resmi Gupta, Megha B Shah, Pavnit Kukreja, David G Standaert and 2 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders clinical practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT03781167 phase3completednot on this map

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

TypeinterventionalSponsorAbbVieRan2019 to 2022Enrolled244ConditionsParkinson's Disease (PD)ArmsABBV-951
NCT04379050 phase3completednot on this map

An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

TypeinterventionalSponsorAbbVieRan2020 to 2026Enrolled130ConditionsParkinson's Disease (PD)ArmsABBV-951
NCT04380142 phase3completednot on this map

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

TypeinterventionalSponsorAbbVieRan2020 to 2021Enrolled174ConditionsParkinson's Disease (PD)ArmsABBV-951, Placebo for Levodopa/Carbidopa (LD/CD), Levodopa/Carbidopa (LD/CD), Placebo for ABBV-951
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
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

12 authors.

Jason AldredSelkirk Neurology and Inland Northwest Research, Spokane, Washington, USA.ORCID https://orcid.org/0000-0001-7441-0967
Manon BouchardClinique Neuro-Lévis and Centre de Recherche St-Louis, Lévis, Québec, Canada.
Juan Carlos Martínez-CastrilloDepartment of Neurology, Ramón y Cajal University Hospital, Madrid, Spain.
Michael J SoileauTexas Movement Disorder Specialists, Georgetown, Texas, USA.
Amy M SpiegelAbbVie Inc., North Chicago, Illinois, USA.
Lars BergmannAbbVie Inc., North Chicago, Illinois, USA.
Resmi GuptaAbbVie Inc., North Chicago, Illinois, USA.
Megha B ShahAbbVie Inc., North Chicago, Illinois, USA.
Pavnit KukrejaAbbVie Inc., North Chicago, Illinois, USA.
David G StandaertCenter for Neurodegeneration and Experimental Therapeutics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Stuart H IsaacsonParkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, USA.
Tove HenriksenDepartment of Neurology, Movement Disorder Clinic, University Hospital of Bispebjerg, Copenhagen, Denmark.

Funding

AbbVie
6 · The paper itself

Abstract

backgroundAs Parkinson's disease (PD) progresses, managing symptoms becomes increasingly difficult. Foslevodopa/foscarbidopa (LDp/CDp), a 24-hour/day continuous subcutaneous infusion of levodopa/carbidopa (LD/CD) prodrugs, improves motor complications. The feasibility and sustainability of LDp/CDp monotherapy warrants investigation.

objectiveThe aim was to report the efficacy and safety of LDp/CDp monotherapy and combination therapy.

methodsThis post hoc analysis assessed patients with PD and ≥2.5 "Off" hours/day receiving LDp/CDp monotherapy or combination therapy in 3 trials: a 12-week randomized active-controlled trial (RCT) comparing LDp/CDp with oral immediate-release LD/CD (NCT04380142), a 52-week open-label trial of LDp/CDp (NCT03781167), and its 96-week open-label extension study (OLE; NCT04379050). Monotherapy was defined as receiving LDp/CDp without concomitant PD medications; combination therapy was defined as receiving LDp/CDp with other PD medications.

resultsIn the RCT, 74 of 141 patients received LDp/CDp. The 52-week trial enrolled 244 patients; 129 entered the OLE. Of LDp/CDp-treated patients, 19 of 74 (25.7%) in the RCT, 49 of 244 (20.1%) in the 52-week trial, and 46 of 129 (35.7%) in the OLE received monotherapy. In the RCT, mean (standard deviation) change from baseline to week 12 in "Off" time was -4.5 (4.4) and -3.0 (3.5) hours for monotherapy and combination therapy, respectively; +4.1 (3.7) and +3.1 (3.6) hours for "On" time without troublesome dyskinesia; and +4.0 (3.6) and +4.0 (3.9) hours for "On" time without dyskinesia. Efficacy was similar in open-label trials. Improvements in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part II, 39-item Parkinson's Disease Questionnaire, Parkinson's Disease Sleep Scale-2 scores, and overall safety were comparable between monotherapy and combination therapy groups.

conclusionsLDp/CDp monotherapy treatment may be suitable for up to 96 weeks.

Indexed as

Antiparkinson AgentsCarbidopaLevodopaParkinson DiseaseAgedDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsLevodopafoslevodopa/foscarbidopamonotherapyParkinson's diseasesubcutaneous infusion

Identifiers

PMID40736131
PMCPMC12839491

What OpenQuestion holds

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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.