Evidence map›Paper›PMID 31081793›Full record

Trial reportJournal of Parkinson's disease2019

Prevalence of Dyskinesia and OFF by 30-Minute Intervals Through the Day and Assessment of Daily Episodes of Dyskinesia and OFF: Novel Analyses of Diary Data from Gocovri Pivotal Trials.

Robert A Hauser, Daniel E Kremens, Lawrence W Elmer, David L Kreitzman, Ryan R Walsh, Reed Johnson, Robert Howard, Jack T Nguyen, Rajiv Patni

Open access · bronzeAbstract readClinical Trial, Phase IIIControlled Clinical TrialMulticenter Study
In one paragraph

Trial report in Journal of Parkinson's disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

12 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
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  4. Article
  5. Article
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  9. Article
  10. Medical Management and Prevention of Motor Complications in Parkinson's Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  11. Article
  12. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA.Journal of Parkinson's disease · 2019
    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

9 authors at 5 institutions in 1 country.

Robert A HauserUniversity of South Florida, Tampa, FL, USA.
Daniel E KremensThomas Jefferson University, Philadelphia, PA, USA.
Lawrence W ElmerUniversity of Toledo College of Medicine, Toledo, OH, USA.
David L KreitzmanParkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, USA.
Ryan R WalshMuhammad Ali Parkinson Center at Barrow Neurological Institute, Phoenix, AZ, USA.
Reed JohnsonAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Robert HowardVeridical Solutions, Del Mar, CA, USA.
Jack T NguyenAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Rajiv PatniAdamas Pharmaceuticals, Inc., Emeryville, CA, USA.
Adamas Pharmaceuticals (United States) · USBarrow Neurological Institute · USThomas Jefferson University · USUniversity of South Florida · USUniversity of Toledo · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParkinson's disease (PD) patients using levodopa commonly develop dyskinesia and OFF episodes that reduce quality of life.

objectiveEvaluate prevalence of troublesome dyskinesia and OFF through the day, assessed by 30-minute intervals, as well as the mean number and duration of troublesome dyskinesia and OFF episodes, transitions between PD states, and effects of Gocovri® (amantadine) extended release capsules on these episodes.

methodsEvaluate diary data from pooled Gocovri phase 3, placebo-controlled trials-analyzed for 17 hours following wake-up-at baseline and week 12.

resultsDiaries were evaluable for 162 patients. At baseline, 67% of patients woke up OFF, with prevalence decreasing to 13% at 2 hours and then remaining relatively steady at ∼12% (range, 6-17%) across half-hour intervals thereafter. Troublesome dyskinesia prevalence rose steadily from 5% to 24% over the first 2 hours, then fluctuated between 20% and 44% through the rest of the waking day. At baseline, patients experienced a mean of 3.0 daily episodes of troublesome dyskinesia (average duration 2.0 hours each), and 2.2 daily episodes of OFF (average duration 1.1 hour each). At week 12, Gocovri-treated patients showed greater reductions than placebo in troublesome dyskinesia and OFF episodes per day (treatment difference: -1.0 episodes and -0.4 episodes, respectively) and average episode duration (treatment difference: -0.6 hours and -0.3 hours, respectively). Mean duration of individual episodes of ON without troublesome dyskinesia (Good ON) increased by 5.0 hours for Gocovri, compared with 2.0 hours for placebo. Patients taking Gocovri experienced 2.2 fewer transitions between states than patients taking placebo.

conclusionsTroublesome dyskinesia and OFF occurred in the morning and throughout the waking day. Gocovri-treated patients experienced fewer, shorter episodes of both troublesome dyskinesia and OFF, thereby increasing the duration of continuous Good ON episodes and reducing the frequency of transitions between motor states.

Indexed as

Outcome Assessment, Health CareAdultAgedAged, 80 and overAmantadineAntiparkinson AgentsDelayed-Action PreparationsDouble-Blind MethodDyskinesia, Drug-InducedFemaleHumansLevodopaMaleMiddle AgedParkinson DiseasePrevalenceAmantadineAntiparkinson AgentsDelayed-Action PreparationsLevodopaAmantadinedelayed-action preparationsdouble-blind methoddyskinesiasepisodeshumanslevodopaOFFParkinson diseasetransitionstreatment

Identifiers

PMID31081793
PMCPMC6700613
OpenAlexW2943895260

What OpenQuestion holds

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LicenceCC BY-NC
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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.