A Randomized Clinical Trial to Evaluate the Effects of Safinamide on Apathetic Non-demented Patients With Parkinson's Disease
Kulisevsky, Jaime (Institut d'Investigació Biomèdica Sant Pau)
Martinez-Horta, Saul (Institut d'Investigació Biomèdica Sant Pau)
Campolongo, Antonia (Institut d'Investigació Biomèdica Sant Pau)
Pascual-Sedano, Berta María (Institut d'Investigació Biomèdica Sant Pau)
Marín-Lahoz, Juan (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Bejr-kasem, Helena (Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas)
Aracil-Bolaños, Ignacio (Institut d'Investigació Biomèdica Sant Pau)
Horta, Andrea (Institut d'Investigació Biomèdica Sant Pau)
Puig-Davi, Arnau (Universitat Autònoma de Barcelona)
Pagonabarraga Mora, Javier (Institut d'Investigació Biomèdica Sant Pau)
Universitat Autònoma de Barcelona

Date:	2022
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 [p = 0. 059] mediated by a more marked decrease in AS score with safinamide (−7. 5 ± 6. 9) than with placebo (−2. 8 ± 5. 7). Post-hoc analysis (paired t-test) showed a significant positive change in the AS score between 12-week and 24-week [p = 0. 001] only in the active group. No significant or trend changes were found for any of the secondary outcome variables. Adverse events were few and only mild in both treatment groups. Conclusions: Safinamide was safe and well-tolerated, but failed to provide evidence of improved apathy. The positive trend observed in the post-hoc analyses deserves to be studied in depth in larger studies. Trial Registration: EudraCT 2017-003254-17.
Grants:	Instituto de Salud Carlos III PI15/00962 Instituto de Salud Carlos III PI18/01717
Note:	Altres ajuts: CERCA; CIBERNED; La Marató de TV3 (2014/U/477, 20142910); Fondo Europeo de Desarrollo Regional (FEDER).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Parkinson's disease ; Apathy ; Safinamide ; RCT-randomized controlled trial ; Clinical trial
Published in:	Frontiers in neurology, Vol. 13 (february 2022) , p. 866502, ISSN 1664-2295

DOI: 10.3389/fneur.2022.866502
PMID: 35720066

11 p, 1.1 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles