Evidence map›Paper›PMID 27802242›Full record

Trial reportJournal of Parkinson's disease2017

Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis.

Carlo Cattaneo, Paolo Barone, Erminio Bonizzoni, Marco Sardina

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 48 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 6 pooled it
4.3field-weighted citation impact, top 6% 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

48 citing papers in PubMed, 6 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Implications of dopaminergic medication withdrawal in Parkinson's disease.Journal of neural transmission (Vienna, Austria : 1996) · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. NabioRxiv : the preprint server for biology · 2026
    Article
  12. Article
  13. Article
  14. Article
  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. Article
  17. Review
  18. Review
  19. Article
  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

4 authors at 3 institutions in 2 countries.

Carlo CattaneoMedical Department, Zambon SpA, Bresso (MI), Italy.
Paolo BaroneCentre for Neurodegenerative Diseases (CEMAND), Department of Medicine and Surgery, University of Salerno, Baronissi (SA), Italy.
Erminio BonizzoniDepartment of Clinical Science and Community, Section of Medical Statistics and Biometry "GA Maccacaro", University of Milan, Milan, Italy.
Marco SardinaR&D Department, Zambon SpA, Bresso (MI), Italy.
Zambon (Italy) · ITUniversity of Milan · ITUniversity of Salerno · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPain, a frequent non-motor symptom in Parkinson's Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients.

objectiveTo investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE.

methodsThis post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment.

resultsThe percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the "Bodily discomfort" domain.Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect.

conclusionsThese results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit.

Indexed as

Outcome Assessment, Health CareAdultAgedAlanineBenzylaminesDouble-Blind MethodFemaleHumansMaleMiddle AgedPainParkinson DiseaseAlanineBenzylaminessafinamideglutamatepainParkinson’s diseaseSafinamide

Identifiers

PMID27802242
PMCPMC5302028
OpenAlexW2530613825

What OpenQuestion holds

Textmetadata
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.