Evidence map›Paper›PMID 28725701›Full record

ArticleNPJ Parkinson's disease2016

Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients.

Miho Murata, Masahito Mihara, Kazuko Hasegawa, Beomseok Jeon, Chon-Haw Tsai, Noriko Nishikawa, Tomoko Oeda, Masayuki Yokoyama, Weining Z Robieson, Davis Ryman and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ Parkinson's disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01960842 (An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT01960842 phase3completednot on this map

An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication

TypeinterventionalSponsorAbbVieRan2013 to 2015Enrolled31ConditionsAdvanced Parkinson's DiseaseArmsLevodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube, J-tube
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Recent Advances in Drug Therapy for Parkinson's Disease.Internal medicine (Tokyo, Japan) · 2023
    Review
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Article
  9. 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

13 authors at 9 institutions in 4 countries.

Miho MurataNational Center of Neurology and Psychiatry, Tokyo, Japan.
Masahito MiharaOsaka University Hospital, Suita, Japan.
Kazuko HasegawaNational Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.
Beomseok JeonSeoul National University Hospital, Seoul, Korea.
Chon-Haw TsaiDepartment of Neurology, China Medical University Hospital and Medical College, China Medical University, Taichung, Taiwan.
Noriko NishikawaEhime University Hospital, Matsuyama, Japan.
Tomoko OedaNational Hospital Organization Utano Hospital, Kyoto, Japan.
Masayuki YokoyamaAbbVie Inc, Tokyo, Japan.
Weining Z RobiesonAbbVie Inc, North Chicago, IL, USA.
Davis RymanAbbVie Inc, North Chicago, IL, USA.
Susan EatonAbbVie Inc, North Chicago, IL, USA.
Krai ChatamraAbbVie Inc, North Chicago, IL, USA.
Janet BeneshAbbVie Inc, North Chicago, IL, USA.
AbbVie (United States) · USABB (Japan) · JPChina Medical University · TWEhime University Hospital · JPNational Center of Neurology and Psychiatry · JPNational Hospital Organization · JPNational Sagamihara Hospital · JPOsaka University Hospital · JPSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a previous multinational, randomized, double-blind, double-dummy study, levodopa-carbidopa intestinal gel (LCIG) was tolerable and significantly improved 'off' time in advanced Parkinson's disease (PD) patients. However, efficacy and safety in the Asian population has not yet been demonstrated. In this open-label study, efficacy and safety of LCIG were assessed in Japanese, Korean, and Taiwanese advanced PD patients with motor complications not adequately controlled by available PD medication. The patients were treated with LCIG monotherapy for 12 weeks. The primary end point was the mean change from baseline to week 12 in 'off' time, as reported in the PD Symptom Diary, normalized to a 16 h waking day and analyzed by a mixed-model repeated-measures analysis. Adverse events (AEs) were recorded. Thirty-one patients were enrolled (23 Japanese, 4 Taiwanese, 4 Korean) and 28 (90%) completed the study. For those who completed the study, the mean (s.d.) total daily levodopa dose from LCIG was 1,206.3 (493.6) mg/day at final visit (

Identifiers

PMID28725701
PMCPMC5516619
OpenAlexW2545269984

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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.