Evidence map›Paper›PMID 35077474›Full record

Trial reportPloS one2022

Effects of rasagiline on Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain in patients with Parkinson's disease: A post-hoc analysis of clinical trials in Japan.

Nobutaka Hattori, Atsushi Takeda, Yuki Hanya, Tadayuki Kitagawa, Masaki Arai, Yoshihiko Furusawa, Hideki Mochizuki, Masahiro Nagai, Ryosuke Takahashi

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT02337725 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa

TypeinterventionalSponsorTakedaRan2015 to 2016Enrolled244ConditionsParkinson's DiseaseArmsTVP-1012, Placebo
NCT02337738 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off

TypeinterventionalSponsorTakedaRan2015 to 2016Enrolled404ConditionsParkinson's DiseaseArmsTVP-1012 1mg, TVP-1012 0.5mg, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. Article
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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 6 institutions in 1 country.

Nobutaka HattoriDepartment of Neurology, Juntendo University Faculty of Medicine, Tokyo, Japan.ORCID 0000-0002-2034-2556
Atsushi TakedaDepartment of Neurology, National Hospital Organization Sendai Nishitaga Hospital, Miyagi, Japan.ORCID 0000-0001-8039-2486
Yuki HanyaJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Tadayuki KitagawaJapan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Masaki AraiJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Yoshihiko FurusawaJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Hideki MochizukiDepartment of Neurology, Osaka University Graduate School of Medicine, Osaka, Japan.
Masahiro NagaiClinical Research Support Center, Ehime University Hospital, Ehime, Japan.ORCID 0000-0001-5473-4913
Ryosuke TakahashiDepartment of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takeda (Japan) · JPEhime University Hospital · JPJuntendo University · JPKyoto University · JPThe University of Osaka · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdentifying the factors that influence health-related quality of life (HRQoL) is of great scientific interest, but a potential causal relationship between treatment and HRQoL has yet to be fully elucidated. Japanese patients reported better HRQoL outcomes on the Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain, a 6-question subset of the PDQ-39 which is considered to reflect the emotional aspects of the disease-specific HRQoL, when treated with rasagiline, than placebo, in both a monotherapy clinical trial (NCT02337725) and an adjunctive therapy clinical trial in patients with wearing-off phenomena (NCT02337738).

objectiveTo investigate how rasagiline exerts its effect on the PDQ-39 emotional well-being domain in Japanese patients with Parkinson's disease.

methodsA path analysis was performed to assess the direct treatment effects of rasagiline on the PDQ-39 emotional well-being domain and the effects mediated indirectly through the influence on items related to motor symptoms by a post-hoc analysis of two clinical trials in Japan.

resultsIn the monotherapy trial, the PDQ-39 emotional well-being domain was mainly affected indirectly through items related to motor symptoms (80.7%) composed of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (67.2%) and Part III (13.5%). In the adjunctive therapy trial, the PDQ-39 emotional well-being domain was also mainly influenced indirectly through effects on items related to motor symptoms (1 mg/day: 54.7%, 0.5 mg/day: 57.6%) composed of MDS-UPDRS Part II (1 mg/day: 35.6%, 0.5 mg/day: 40.9%), Part III (1 mg/day: 8.0%, 0.5 mg/day: 8.3%) and mean daily OFF-time (1 mg/day: 11.1%, 0.5 mg/day: 8.4%).

conclusionsThe effects of rasagiline on the PDQ-39 emotional well-being domain were mediated primarily by influence on the subjective aspects of motor experiences of daily living.

Indexed as

Quality of LifeAgedAntiparkinson AgentsEmotionsFemaleHumansIndansJapanMaleParkinson DiseaseSurveys and QuestionnairesTreatment OutcomeAntiparkinson AgentsIndansrasagiline

Identifiers

PMID35077474
PMCPMC8789184
OpenAlexW4207069160

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.