Evidence map›Paper›PMID 41984314›Full record

Trial reportAdvances in therapy2026

Foslevodopa/Foscarbidopa Subcutaneous Infusion Safety and Efficacy in Patients with and Without Prior Deep Brain Stimulation.

Tove Henriksen, Juan Carlos Martínez-Castrillo, Mark H B Huisman, Sara Dhanani, Elizabeth Peckham, Jason Aldred, Lars Bergmann, Megha B Shah, Resmi Gupta, Pavnit Kukreja and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03781167 (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), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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.

Tove HenriksenMovement Disorder Clinic, Department of Neurology, University Hospital of Bispebjerg, Bispebjerg Bakke 23, 2400 NV, Copenhagen, Denmark. Tove.Henriksen@regionh.dk.
Juan Carlos Martínez-CastrilloMovement Disorders Unit, Ramón y Cajal University Hospital, IRYCIS, Madrid, Spain.
Mark H B HuismanDepartment of Neurology, St. Antonius Hospital, Hospital Utrecht, Utrecht, The Netherlands.
Sara DhananiBanner Sun Health Research Institute, Sun City, AZ, USA.
Elizabeth PeckhamCentral Texas Neurology Consultants, Round Rock, TX, USA.
Jason AldredSelkirk Neurology, Spokane, WA, USA.
Lars BergmannAbbVie Inc., North Chicago, IL, USA.
Megha B ShahAbbVie Inc., North Chicago, IL, USA.
Resmi GuptaAbbVie Inc., North Chicago, IL, USA.
Pavnit KukrejaAbbVie Inc., North Chicago, IL, USA.
Juan Carlos ParraAbbVie Inc., North Chicago, IL, USA.
Victor S C FungMovement Disorders Unit, Westmead Hospital, Westmead, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAs Parkinson's disease (PD) advances, limitations of oral medication include pill burden, increasing "Off" time, and "On" time with bothersome dyskinesia. Deep brain stimulation (DBS) can improve motor complications, but disease progression may warrant further intervention later. An approved nonsurgical option, continuous subcutaneous infusion of foslevodopa/foscarbidopa (LDp/CDp), has been shown to improve motor fluctuations, though the impact of prior DBS on its efficacy and safety is unknown.

methodsPost hoc analysis of a 52-week open-label phase 3 trial (NCT03781167) evaluated baseline characteristics, safety, and efficacy in patients treated with LDp/CDp with or without prior DBS. Fisher's exact test, t test, Wilcoxon rank-sum test, and analysis of covariance were performed.

resultsTwenty-four (9.8%) of 244 patients received prior DBS. Both groups had similar baseline characteristics, although prior patients treated with DBS had significantly more time since diagnosis and more "speech" and "gait" impairment (Movement Disorders Society-Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Parts II/III single items). Both groups showed significant within-group improvements in "Off" time and "On" time without dyskinesia, and the between-group difference for these improvements was not significant, indicating LDp/CDp had efficacy regardless of DBS exposure. The no DBS group had significant improvement in sleep and quality of life, while the prior DBS group had nonsignificant trends in the same direction. The no DBS group had significant improvement in MDS-UPDRS Part II score but worsening in Part III score, as expected with advancing disease; change from baseline in the prior DBS group was not significant. The safety data were similar in both groups, with the only significant difference being a higher percentage of prior patients treated with DBS experiencing severe treatment-emergent adverse events than no DBS (45.8% vs 23.6%).

conclusionWhile limited by small prior DBS patient numbers, this post hoc study suggests generally similar overall baseline, safety, and efficacy profiles in LDp/CDp-treated prior DBS and no DBS.

trial registrationClinicalTrials.gov identifier NCT03781167.

Indexed as

Antiparkinson AgentsCarbidopaDeep Brain StimulationLevodopaParkinson DiseaseAgedDrug CombinationsFemaleHumansInfusions, SubcutaneousMaleMiddle AgedTreatment OutcomeAntiparkinson AgentsCarbidopaDrug CombinationsLevodopaDeep brain stimulationFoscarbidopaFoslevodopaParkinson’s diseaseSubcutaneous infusion

Identifiers

PMID41984314
PMCPMC13222207

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.