Evidence map›Paper›PMID 35720066›Full record

ArticleFrontiers in neurology2022

A Randomized Clinical Trial to Evaluate the Effects of Safinamide on Apathetic Non-demented Patients With Parkinson's Disease.

Jaime Kulisevsky, Saul Martínez-Horta, Antonia Campolongo, Berta Pascual-Sedano, Juan Marín-Lahoz, Helena Bejr-Kasem, Ignacio Aracil-Bolaños, Andrea Horta-Barba, Arnau Puig-Davi, Javier Pagonabarraga

Open access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 11% 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

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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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

10 authors at 3 institutions in 1 country.

Jaime KulisevskyMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Saul Martínez-HortaMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Antonia CampolongoMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Berta Pascual-SedanoMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Juan Marín-LahozMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Helena Bejr-KasemMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Ignacio Aracil-BolañosMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Andrea Horta-BarbaMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Arnau Puig-DaviMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Javier PagonabarragaMovement Disorders Unit, Neurology Department, Sant Pau Hospital, Barcelona, Spain.
Universitat Autònoma de Barcelona · ESHospital de Sant Pau · ESBiomedical Research Networking Center on Neurodegenerative Diseases · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Apathy is highly prevalent and disabling in Parkinson's disease (PD). Pharmacological options for its management lack sufficient evidence. Objective: We studied the effects of safinamide on apathy in PD. Methods: Prospective, 24-week, two-site, randomized, double-blind, placebo-controlled, parallel-group exploratory study in non-demented PD on stable dopaminergic therapy randomized 1:1 to adjunct safinamide (50 mg/day for 2 weeks and 100 mg/day for 22 weeks) or placebo. The primary endpoint was the mean change from baseline to week 24 on the Apathy Scale (AS) total score. Secondary endpoints included changes in cognition, activities of daily living, motor scores, the impression of change, and safety and tolerability measures. Results: In total, 30 participants (active treatment = 15; placebo = 15; 80% showing clinically significant apathetic symptoms according to the AS) were enrolled, and included in the intention-to-treat analysis. Change in AS (ANOVA) showed a trend to significance [ Conclusions: Safinamide was safe and well-tolerated, but failed to provide evidence of improved apathy. The positive trend observed in the Trial Registration: EudraCT 2017-003254-17.

Indexed as

apathyclinical trialParkinson's diseaseRCT-randomized controlled trialsafinamide

Identifiers

PMID35720066
PMCPMC9201638
OpenAlexW4281682453

What OpenQuestion holds

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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.