Evidence map›Paper›PMID 40417229›Full record

ArticleClinical parkinsonism & related disorders2025

Post hoc exploratory analysis of the effect of foslevodopa/foscarbidopa continuous subcutaneous infusion on nocturia in patients with Parkinson's disease.

K Ray Chaudhuri, Manon Bouchard, Eric Freire-Alvarez, Rajesh Pahwa, Lars Bergmann, Resmi Gupta, Pavnit Kukreja, Megha B Shah, Stuart H Isaacson

2 registry-linked trialsAbstract read
In one paragraph

Article in Clinical parkinsonism & related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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
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

4 citing papers in PubMed.

  1. Article
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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

9 authors.

K Ray ChaudhuriParkinson's Foundation Centre of Excellence, King's College Hospital, London, UK.
Manon BouchardClinique Neuro-Lévis, Université Laval, Lévis, QC, Canada.
Eric Freire-AlvarezNeurology Department, University General Hospital of Elche, Elche, Spain.
Rajesh PahwaParkinson's Disease and Movement Disorder Center, University of Kansas Medical Center, Kansas City, KS, USA.
Lars BergmannAbbVie Inc, North Chicago, IL, USA.
Resmi GuptaAbbVie Inc, North Chicago, IL, USA.
Pavnit KukrejaAbbVie Inc, North Chicago, IL, USA.
Megha B ShahAbbVie Inc, North Chicago, IL, USA.
Stuart H IsaacsonParkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Parkinson's disease (PD) non-motor symptom burden, including nocturia and sleep disturbances, worsens with disease progression. Continuous dopaminergic drug delivery with nocturnal infusion in PD demonstrated improvements in sleep and nocturia. Foslevodopa/foscarbidopa (LDp/CDp) provides 24-hour continuous drug delivery of levodopa/carbidopa (LD/CD) prodrugs via continuous subcutaneous infusion (CSCI). Methods: Least-squares mean nocturia changes (measured via Parkinson's Disease Sleep Scale-2 item 8) in patients with PD from a randomized 12-week phase 3 trial of LDp/CDp CSCI versus oral LD/CD (NCT04380142) and a 52-week open-label LDp/CDp CSCI phase 3 trial (NCT03781167) were analyzed post hoc via mixed-effects regression and analysis of covariance. Correlation coefficients at baseline (BL) and in change from BL to week 12 or week 52 (Δ BL-wk 12 or Δ BL-wk 52) for nocturia and quality of life (QoL, measured as Parkinson's Disease Questionnaire [PDQ-39] Summary Index score) were calculated via Spearman's test. Results: This exploratory analysis demonstrated significant and sustained improvement in nocturia symptoms from BL with LDp/CDp treatment in both the randomized (to week 12; n = 44; nominal p ≤ 0.01) and open-label (to weeks 6, 13, 26, and 52; with n = 176, 149, 107, and 75, respectively; nominal p ≤ 0.001 for all) trials. Nocturia improvement was significantly greater in LDp/CDp- versus oral-treated patients (n = 59; nominal p ≤ 0.05). A significant positive correlation between nocturia and QoL was shown at BL and between Δ BL-wk 12 in the randomized trial (nominal p ≤ 0.05 for both), while open-label results showed no significant correlations. Conclusions: LDp/CDp-treated patients with PD demonstrated significantly improved nocturia with 24-hour therapy, 12-week nocturia improvements were significantly greater than oral therapy, and patient-reported nocturia may correlate with QoL.

Indexed as

FoscarbidopaFoslevodopaNocturiaParkinson’s diseaseSubcutaneous infusion

Identifiers

PMID40417229
PMCPMC12099457

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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.