Evidence map›Paper›PMID 38465885›Full record

Trial reportMovement disorders clinical practice2024

Improved Sleep Correlates with Improved Quality of Life and Motor Symptoms with Foslevodopa/Foscarbidopa.

K Ray Chaudhuri, Maurizio F Facheris, Bruno Bergmans, Filip Bergquist, Susan R Criswell, Jia Jia, Pavnit Kukreja, Yohei Mukai, Amy M Spiegel, Resmi Gupta and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders clinical practice, 2024. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Review
  7. Article
  8. 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

12 authors.

K Ray ChaudhuriParkinson's Foundation International Centre of Excellence, King's College Hospital, London, UK.ORCID https://orcid.org/0000-0003-2815-0505
Maurizio F FacherisAbbVie Inc., North Chicago, Illinois, USA.
Bruno BergmansDepartment of Neurology, AZ St-Jan Brugge-Oostende AV, Bruges, Belgium.ORCID https://orcid.org/0000-0002-1463-8262
Filip BergquistDepartment of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID https://orcid.org/0000-0002-3437-0267
Susan R CriswellMuhammad Ali Parkinson Center, Barrow Neurologic Institute, Phoenix, Arizona, USA.ORCID https://orcid.org/0000-0001-8467-371X
Jia JiaAbbVie Inc., North Chicago, Illinois, USA.
Pavnit KukrejaAbbVie Inc., North Chicago, Illinois, USA.
Yohei MukaiDepartment of Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2930-5003
Amy M SpiegelAbbVie Inc., North Chicago, Illinois, USA.
Resmi GuptaAbbVie Inc., North Chicago, Illinois, USA.
Lars BergmannAbbVie Inc., North Chicago, Illinois, USA.
Rajesh PahwaDepartment of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA.ORCID https://orcid.org/0000-0003-3176-6466

Funding

AbbVie Inc
6 · The paper itself

Abstract

backgroundFoslevodopa/foscarbidopa is a subcutaneous infusion of levodopa/carbidopa prodrugs.

objectivesAssess correlations between sleep and efficacy from interim data of a phase 3 trial of foslevodopa/foscarbidopa (NCT03781167).

methodsPearson correlations between sleep (Parkinson's Disease Sleep Scale-2 [PDSS-2]) and quality of life (QoL; Parkinson's Disease Questionnaire-39), motor experiences of daily living (m-EDL; Movement Disorder Society-Unified Parkinson's Disease Scale Part II), and "Off"/"On" times were calculated for baseline and week 26 improvements. Regression analyses were adjusted for baseline PDSS-2 score.

resultsBaseline sleep correlated moderately with QoL (r = 0.44, P < 0.001) and weakly with m-EDL (r = 0.28; P < 0.001). Sleep improvement weakly correlated with improved "Off" time (r = 0.37; P < 0.001) and QoL (r = 0.36; P < 0.001). Regression analyses demonstrated significant positive associations for improved sleep, "Off" time, QoL, and m-EDL.

conclusionsImproved sleep with foslevodopa/foscarbidopa was associated with improved QoL and "Off" time.

Indexed as

Antiparkinson AgentsCarbidopaDrug CombinationsLevodopaParkinson DiseaseQuality of LifeSleepActivities of Daily LivingAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsLevodopafoslevodopa/foscarbidopainfusion therapyParkinson's diseasepost hoc analysissleep

Identifiers

PMID38465885
PMCPMC11233834

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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.