Evidence map›Paper›PMID 36388237›Full record

ArticleParkinson's disease2022

Effects of Levodopa-Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson's Disease: INSIGHTS Study.

Sun Ju Chung, Matilde Calopa, Maria G Ceravolo, Nicola Tambasco, Angelo Antonini, K Ray Chaudhuri, Weining Z Robieson, Olga Sánchez-Soliño, Cindy Zadikoff, Man Jin and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Parkinson's disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02549092 (An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel), 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
0.6field-weighted citation impact, top 30% 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.

NCT02549092 phase3completednot on this map

An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study

TypeinterventionalSponsorAbbVieRan2015 to 2022Enrolled89ConditionsAdvanced Parkinson's DiseaseArmsOptimized Medical Treatment, Levodopa-Carbidopa Intestinal Gel, Nasojejunal (NJ) tube, Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

11 authors at 7 institutions in 5 countries.

Sun Ju ChungDepartment of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID https://orcid.org/0000-0003-4118-8233
Matilde CalopaDepartment of Neurology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID https://orcid.org/0000-0002-6943-3707
Maria G CeravoloDepartment of Experimental and Clinical Medicine, Neurorehabilitation Clinic, University Hospital of Ancona, Università Politecnica Delle Marche, Ancona, Italy.ORCID https://orcid.org/0000-0002-2694-4638
Nicola TambascoMovement Disorders Center, Perugia General Hospital and University of Perugia, Perugia, Italy.ORCID https://orcid.org/0000-0003-1497-4482
Angelo AntoniniMovement Disorders Unit, Department of Neuroscience, University of Padua, Padua, Italy.ORCID https://orcid.org/0000-0003-1040-2807
K Ray ChaudhuriInstitute of Psychiatry Psychology & Neuroscience, King's College and Parkinson Foundation International Centre of Excellence, King's College Hospital, Denmark Hill, London, UK.ORCID https://orcid.org/0000-0003-2815-0505
Weining Z RobiesonAbbVie Inc., North Chicago, IL, USA.ORCID https://orcid.org/0000-0003-0557-1075
Olga Sánchez-SoliñoAbbVie Inc., North Chicago, IL, USA.ORCID https://orcid.org/0000-0002-8833-2194
Cindy ZadikoffAbbVie Inc., North Chicago, IL, USA.ORCID https://orcid.org/0000-0003-0008-1704
Man JinAbbVie Inc., North Chicago, IL, USA.
Luigi M BarbatoAbbVie Inc., North Chicago, IL, USA.
AbbVie (United States) · USBellvitge University Hospital · ESKing's College Hospital NHS Foundation Trust · GBMarche Polytechnic University · ITUlsan College · KRUniversity of Padua · ITUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nonmotor symptoms (NMS) are common in advanced Parkinson's disease (APD) and reduce health-related quality of life. Objective: The aim of the study was to evaluate levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on NMS in APD. Methods: INSIGHTS was a phase 3b, open-label, randomized, multicenter study in patients with APD (LCIG or OMT, 26 weeks) (NCT02549092). Primary outcomes assessed were total NMS (NMS scale (NMSS) and PD sleep scale (PDSS-2)). Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI-C), and PD Questionnaire-8 (PDQ-8). Additional secondary measures of Patient Global Impression of Change (PGIC), King's PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed. Results: Out of 89 patients randomized, 87 were included in the analysis (LCIG, Conclusions: There were no significant differences between LCIG versus OMT in NMSS or PDSS-2; both LCIG and OMT groups significantly improved from baseline. AEs were consistent with the known safety profile.

Identifiers

PMID36388237
PMCPMC9652073
OpenAlexW4308261157

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.