Evidence map›Paper›PMID 34236101›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2021

Levodopa-Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial.

Eric Freire-Alvarez, Egon Kurča, Lydia Lopez Manzanares, Eero Pekkonen, Cleanthe Spanaki, Paola Vanni, Yang Liu, Olga Sánchez-Soliño, Luigi M Barbato

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report 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 NCT02799381 (An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 4% 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.

NCT02799381 phase3completednot on this map

An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)

TypeinterventionalSponsorAbbVieRan2017 to 2019Enrolled63ConditionsParkinson's Disease (PD)ArmsOptimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy ambulatory infusion pump, Percutaneous endoscopic gastrostomy tube, Jejunal extension tube
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  8. Observational
  9. Article
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  11. Review
  12. Advanced therapies in Parkinson's disease: an individualized approach to their indication.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  13. Monotherapy with infusion therapies - useful or not?Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  14. Observational
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  17. Review
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  19. Article
  20. Current and novel infusion therapies for patients with Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2023
    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

9 authors at 7 institutions in 6 countries.

Eric Freire-AlvarezNeurology Department, University General Hospital of Elche, Elche, Spain.
Egon KurčaDepartment of Neurology, Jessenius Faculty of Medicine, Comenius University, Martin, Slovakia.
Lydia Lopez ManzanaresNeurology Department, University Hospital La Princesa, Madrid, Spain.
Eero PekkonenDepartment of Neurology, Helsinki University Hospital and Department of Clinical Neurosciences (Neurology), University of Helsinki, Helsinki, Finland.
Cleanthe SpanakiNeurology Department, University General Hospital of Heraklion, Heraklion, Greece.
Paola VanniUnit of Neurology, Florence Health Authority, S. M. Annunziata Hospital, Florence, Italy.
Yang LiuStatistics, AbbVie Inc., North Chicago, Illinois, USA.
Olga Sánchez-SoliñoNeuroscience, AbbVie Inc, North Chicago, Illinois, USA.
Luigi M BarbatoNeuroscience, AbbVie Inc, North Chicago, Illinois, USA.
AbbVie (United States) · USComenius University Bratislava · SKHospital General Universitario de Elche · ESHospital Universitario de La Princesa · ESOspedale SS. Annunziata · ITUniversity Hospital of Heraklion · GRUniversity of Helsinki · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are limited data regarding the effectiveness of levodopa-carbidopa intestinal gel (LCIG) for dyskinesia.

objectiveCompare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson's disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS).

methodsThis phase 3b, open-label, multicenter, 12-week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD-related motor and non-motor symptoms, and quality of life (QoL) were also assessed.

resultsDyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; -17.37 ± 2.79) compared with the OMT group (n = 26; -2.33 ± 2.56) after 12 weeks (-15.05 ± 3.20; 95% CI, -21.47 to -8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in "On" time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson's Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment-emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG-treated patients.

conclusionsLCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and non-motor symptoms and QoL. © 2021 AbbVie Inc. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson Movement Disorder Society.

Indexed as

CarbidopaDyskinesiasLevodopaParkinson DiseaseActivities of Daily LivingAntiparkinson AgentsDrug CombinationsGelsHumansQuality of LifeAntiparkinson AgentsCarbidopaDrug CombinationsGelsLevodopaDYSCOVERdyskinesialevodopa-carbidopa intestinal geloptimized medical treatment

Identifiers

PMID34236101
PMCPMC9292774
OpenAlexW3181621905

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.