Evidence map›Paper›PMID 27267880›Full record

Trial reportBMC neurology2016

Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease.

Robert A Hauser, Jaroslaw Slawek, Paolo Barone, Elisabeth Dohin, Erwin Surmann, Mahnaz Asgharnejad, Lars Bauer

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01782222 (A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood), which is not on this map. Cited by 29 papers, 6 of them syntheses that pooled it.

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

NCT01782222 phase4completednot on this map

A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

TypeinterventionalSponsorUCB BIOSCIENCES GmbHRan2013 to 2014Enrolled122ConditionsIdiopathic Parkinson's DiseaseArmsRotigotine, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. A meta-analysis evaluating effects of the rotigotine in Parkinson's disease, focusing on sleep disturbances and activities of daily living.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Neurotransmitter Systems in Alzheimer's Disease.Current issues in molecular biology · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
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  15. Review
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  17. Article
  18. Disordered Decision Making: A Cognitive Framework for Apathy and Impulsivity in Huntington's Disease.Movement disorders : official journal of the Movement Disorder Society · 2022
    Review
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  20. 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

7 authors.

Robert A HauserParkinson's Disease and Movement Disorders Center, USF Health - Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL, USA. rhauser@health.usf.edu.
Jaroslaw SlawekDepartment of Neurological-Psychiatric Nursing, Medical University of Gdańsk and Department of Neurology, St Adalbert Hospital, Gdańsk, Poland.
Paolo BaroneNeurodegenerative Disease Center, University of Salerno, Salerno, Italy.
Elisabeth DohinUCB Pharma, Brussels, Belgium.
Erwin SurmannUCB Pharma, Monheim am Rhein, Germany.
Mahnaz AsgharnejadUCB Pharma, Raleigh, NC, USA.
Lars BauerUCB Pharma, Monheim am Rhein, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine transdermal patch on apathy and motor symptoms in patients with Parkinson's disease (PD).

methodsPatients with PD-associated apathy (Unified Parkinson's Disease Rating Scale [UPDRS] I item 4 [motivation] ≥2 and patient-rated Apathy Scale [AS] ≥14) were randomized 1:1:1 to "low-dose" rotigotine (≤6 mg/24 h for early PD [those not receiving levodopa] or ≤8 mg/24 h for advanced PD [those receiving levodopa]), "high-dose" rotigotine (≤8 mg/24 h for early PD or ≤16 mg/24 h for advanced PD), or placebo, and maintained at optimal/maximal dose for 12 weeks. Coprimary efficacy variables were: change from baseline to End of Maintenance in patient-rated AS and UPDRS II + III total score. Recruitment was stopped after an interim futility analysis; therefore, all p values are exploratory.

resultsOf 122 patients randomized, 81.1 % completed the study (placebo, n = 32/40 [80.0 %]; low-dose rotigotine, n = 30/41 [73.2 %]; high-dose rotigotine, n = 37/41 [90.2 %]). No treatment difference was observed in the change in patient-rated AS (least squares mean [95 % confidence interval (CI)] difference: low-dose, 0.04 [-2.42, 2.50], p =0.977; high-dose, -0.22 [-2.61, 2.18], p = 0.859). Rotigotine improved UPDRS II + III total scores versus placebo (least squares mean [95 % CI] treatment difference: low-dose, -7.29 [-12.30, -2.28], p = 0.005; high-dose, -6.06 [-10.90, -1.21], p = 0.015), and the "mood/apathy" domain of the Non-Motor Symptom Scale as rated by the investigator (secondary outcome). The most frequent adverse events in rotigotine-treated patients were application site reactions, somnolence, and nausea.

conclusionsRotigotine did not improve PD-associated apathy as rated by the patient but provided clinically relevant improvement in motor control and activities of daily living.

trial registrationClinicalTrials.gov identifier NCT01782222 . Trial registration date: January 30, 2013.

Indexed as

Activities of Daily LivingAdultAgedAntiparkinson AgentsApathyDopamine AgonistsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLevodopaMaleMiddle AgedParkinson DiseaseTetrahydronaphthalenesThiophenesAntiparkinson AgentsDopamine AgonistsLevodoparotigotineTetrahydronaphthalenesThiophenesApathyParkinson’s diseaseRotigotine transdermal patchTreatment

Identifiers

PMID27267880
PMCPMC4895976

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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.