Evidence map›Paper›PMID 33073879›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2021

Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients with Motor Fluctuations.

Atsushi Takeda, Ryosuke Takahashi, Yoshio Tsuboi, Masahiro Nomoto, Tetsuya Maeda, Akihisa Nishimura, Kazuo Yoshida, Nobutaka Hattori

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. Cited by 25 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Objective assessment of the effects of opicapone in Parkinson's disease through kinematic analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Recent Advances in Drug Therapy for Parkinson's Disease.Internal medicine (Tokyo, Japan) · 2023
    Review
  18. Article
  19. Review
  20. Article
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

8 authors at 7 institutions in 1 country.

Atsushi TakedaNational Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan.
Ryosuke TakahashiDepartment of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-1407-9640
Yoshio TsuboiDepartment of Neurology, Fukuoka University Hospital, Fukuoka, Japan.
Masahiro NomotoDepartment of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Toon, Japan.
Tetsuya MaedaDivision of Neurology and Gerontology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Shiwa, Japan.
Akihisa NishimuraDepartment of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Kazuo YoshidaDepartment of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Nobutaka HattoriDepartment of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Ono Pharmaceutical (Japan) · JPFukuoka University Hospital · JPIwate Medical University · JPJuntendo University · JPKyoto University · JPSaiseikai Ibaraki Hospital · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis placebo-controlled, randomized study evaluated the efficacy and safety of opicapone 25-mg and 50-mg tablets in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations.

methodsJapanese adults (n = 437, age 39-83 years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria) received opicapone 25-mg (n = 145), opicapone 50-mg (n = 145), or placebo (n = 147) tablets over the double-blind treatment period (14-15 weeks). The primary efficacy assessment was change in OFF-time; secondary efficacy assessments included OFF/ON-time responders (≥1 hour change from baseline), total ON-time, ON-time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale.

resultsThe least squares mean (standard error) change in OFF-time from baseline to the last visit was -0.42 (0.21) hour for the placebo group, -1.16 (0.22) hour for the opicapone 25 mg group, and -1.04 (0.21) hour for the opicapone 50 mg group. The percentage of ON-time responders, changes in total ON-time/ON-time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II (at OFF) all showed statistically significant improvements versus placebo for both opicapone tablet doses (P < 0.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05). Adverse events were more common in patients treated with opicapone 25 mg (60.0%) or opicapone 50 mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25 mg, 9.0%; opicapone 50 mg, 12.4%).

conclusionsIn Japanese patients, both opicapone 25 and 50 mg were significantly more effective than placebo with no dose-dependent difference in efficacy, and both doses were well tolerated. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Parkinson DiseaseAdultAgedAged, 80 and overAntiparkinson AgentsDouble-Blind MethodHumansJapanLevodopaMiddle AgedOxadiazolesTreatment OutcomeUnited KingdomAntiparkinson AgentsLevodopaopicaponeOxadiazolesJapaneseopicaponeParkinson's diseaserandomized controlled trial

Identifiers

PMID33073879
PMCPMC7983910
OpenAlexW3093016881

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.