A Randomized Clinical Trial to Evaluate the Effects of Safinamide on Apathetic Non-demented Patients With Parkinson's Disease
Por:
Kulisevsky, J, Martinez-Horta, S, Campolongo, A, Pascual-Sedano, B, Marin-Lahoz, J, Bejr-kasem, H, Aracil-Bolanos, I, Horta-Barba, A, Puig-Davi, A, Pagonabarraga, J
Publicada:
2 jun 2022
Resumen:
BackgroundApathy is highly prevalent and disabling in Parkinson's disease (PD). Pharmacological options for its management lack sufficient evidence. ObjectiveWe studied the effects of safinamide on apathy in PD. MethodsProspective, 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. ResultsIn 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. ConclusionsSafinamide 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.
Filiaciones:
Kulisevsky, J:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Univ Oberta Catalunya UOC, Hosp Quiron Dexeus, Neurol Dept, Barcelona, Spain
Martinez-Horta, S:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Campolongo, A:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Univ Oberta Catalunya UOC, Hosp Quiron Dexeus, Neurol Dept, Barcelona, Spain
Pascual-Sedano, B:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Univ Oberta Catalunya UOC, Hosp Quiron Dexeus, Neurol Dept, Barcelona, Spain
Marin-Lahoz, J:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Bejr-kasem, H:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Aracil-Bolanos, I:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Horta-Barba, A:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Puig-Davi, A:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Pagonabarraga, J:
St Pau Hosp, Neurol Dept, Movement Disorders Unit, Barcelona, Spain
Univ Autonoma Barcelona UAB, Med Dept, Barcelona, Spain
Inst Invest Biomed St Pau IIB St Pau, Barcelona, Spain
Ctr Invest Red Enfermedades Neurodegenerat CIBERNE, Caceres, Spain
Green Published, gold, All Open Access; Gold
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