Evidence map›Paper›PMID 25545465›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2015

Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results.

Hubert H Fernandez, David G Standaert, Robert A Hauser, Anthony E Lang, Victor S C Fung, Fabian Klostermann, Mark F Lew, Per Odin, Malcolm Steiger, Eduard Z Yakupov and 8 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03602924 (Long-term Safety and Effectiveness in Motor and Non-motor Symptoms of Levodopa-carbidopa Intestinal Gel Infusion in Advanced Parkinson's Disease Patients With Motor Fluctuations), which is not on this map. Cited by 128 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
128citing papers in PubMed, 10 pooled it
–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.

NCT03602924 unknown statusnot on this map

Long-term Safety and Effectiveness in Motor and Non-motor Symptoms of Levodopa-carbidopa Intestinal Gel Infusion in Advanced Parkinson's Disease Patients With Motor Fluctuations

TypeobservationalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2008 to 2018Enrolled40ConditionsParkinson Disease
3 · Its place in the literature

Who cites it

128 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Translating Evidence to Advanced Parkinson's Disease Patients: A Systematic Review and Meta-Analysis.Movement disorders : official journal of the Movement Disorder Society · 2021
    Pooled it
  7. Pooled it
  8. Suicide in Parkinson's disease.Journal of neurology, neurosurgery, and psychiatry · 2019
    Pooled it
  9. Pooled it
  10. Pooled it
  11. Levodopa-Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial.Movement disorders : official journal of the Movement Disorder Society · 2021
    Trial
  12. Trial
  13. Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.Movement disorders : official journal of the Movement Disorder Society · 2016
    Trial
  14. Trial
  15. Review
  16. Review
  17. Review
  18. Device aided therapies in Parkinson disease: an expert view on apomorphine.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Review
  19. Observational
  20. Observational

68 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Hubert H FernandezCenter for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
David G Standaert
Robert A Hauser
Anthony E Lang
Victor S C Fung
Fabian Klostermann
Mark F Lew
Per Odin
Malcolm Steiger
Eduard Z Yakupov
Sylvain Chouinard
Oksana Suchowersky
Jordan Dubow
Coleen M Hall
Krai Chatamra
Weining Z Robieson
Janet A Benesh
Alberto J Espay

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. L-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces L-dopa-plasma-level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, "on" time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks.

Indexed as

GelsAdultAgedAntiparkinson AgentsCarbidopaDrug CombinationsFemaleHumansIntestinesLevodopaMaleMiddle AgedParkinson DiseaseProspective StudiesSeverity of Illness IndexTreatment OutcomeAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationDrug CombinationsGelsLevodopadyskinesiainfusionlevodopa-carbidopa intestinal gel“off” timepercutaneous endoscopic gastrojejunostomy

Identifiers

PMID25545465
PMCPMC4674978

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.