Evidence map›Paper›PMID 28777756›Full record

Trial reportJournal of Parkinson's disease2017

Long-Term Effects of Safinamide on Mood Fluctuations in Parkinson's Disease.

Carlo Cattaneo, Thomas Müller, Erminio Bonizzoni, Gabriele Lazzeri, Ioannis Kottakis, Charlotte Keywood

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of Parkinson's disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 12% 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

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
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  14. Novel and experimental therapeutics for the management of motor and non-motor Parkinsonian symptoms.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Review
  15. Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Observational
  16. Fatigue in fluctuating Parkinson's disease patients: possible impact of safinamide.Journal of neural transmission (Vienna, Austria : 1996) · 2023
    Article
  17. 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

6 authors at 3 institutions in 3 countries.

Carlo CattaneoDepartment of Medical, Zambon SpA, Bresso (MI), Italy.
Thomas MüllerDepartment of Neurology, St. Joseph Hospital Berlin-Weißensee, Berlin, Germany.
Erminio BonizzoniDepartment of Clinical Science and Community, Section of Medical Statistics and Biometry "GA Maccacaro", University of Milan, Milan, Italy.
Gabriele LazzeriDepartment of Medical, Zambon SpA, Bresso (MI), Italy.
Ioannis KottakisDepartment of Medical, Zambon SpA, Bresso (MI), Italy.
Charlotte KeywoodDepartment of R&D, Zambon SpA, Bresso (MI), Italy.
Zambon (Italy) · ITSt. Joseph-Krankenhaus · DEUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMood disorders are very frequent in Parkinson's Disease (PD), and their effective treatment is still a major unresolved issue: growing evidence suggests that glutamatergic system dysfunction is directly involved. Safinamide is a drug with an innovative mechanism of action, dopaminergic and non-dopaminergic, that includes the reversible inhibition of the monoamine oxidase-B (MAO-B) enzyme and the modulation of excessive glutamate release through the use- and state-dependent blockade of the sodium channels.

objectiveTo investigate the effects of safinamide on mood over two-year treatment in PD patients with motor fluctuations.

methodsThis was a post-hoc analysis of the data from studies 016 and 018. The analysis focused on outcomes related to mood, namely: scores of the "Emotional well-being" domain of the Parkinson's Disease Questionnaire (PDQ-39), scores of the GRID Hamilton Rating Scale for Depression (GRID-HAMD) and the proportion of patients reporting depression as an adverse event over the entire treatment period.

resultsSafinamide, compared to placebo, significantly improved the PDQ-39 "Emotional well-being" domain after6-months (p = 0.0067) and 2 years (p = 0.0006), as well as the GRID-HAMD (p = 0.0408 after 6 months and p = 0.0027 after 2 years). Significantly fewer patients in the safinamide group, compared to placebo, experienced depression as adverse event (p = 0.0444 after 6 months and p = 0.0057 after 2 years).

conclusionThe favorable effect of safinamide on mood may be explained by the improvement in wearing off and by its modulation of glutamatergic hyperactivity and reversible MAO-B inhibition. Prospective studies are warranted to investigate this potential benefit.

Indexed as

AlanineBenzylaminesDouble-Blind MethodEnzyme InhibitorsFemaleHumansInternational CooperationLongitudinal StudiesMaleMood DisordersOutcome Assessment, Health CareParkinson DiseasePsychiatric Status Rating ScalesSeverity of Illness IndexTime FactorsAlanineBenzylaminesEnzyme InhibitorssafinamideGlutamatemoodParkinson’s diseasesafinamide

Identifiers

PMID28777756
PMCPMC5676861
OpenAlexW2743373424

What OpenQuestion holds

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LicenceCC BY-NC
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.