TY - JOUR
T1 - Effects of safinamide on pain in patients with fluctuating Parkinson's disease
AU - Grigoriou, Sotirios
AU - Martínez-Martín, Pablo
AU - Ray Chaudhuri, K.
AU - Rukavina, Katarina
AU - Leta, Valentina
AU - Hausbrand, Denise
AU - Falkenburger, Björn
AU - Odin, Per
AU - Reichmann, Heinz
N1 - Funding Information:
The study was funded by Zambon SpA with an unconditional research grant. In addition, the study was funded by MultiPark, the strategic research area for neuroscience at Lund University; the Swedish Parkinson Foundation; the Swedish Parkinson Academy and the Faculty of Medicine at Lund University.
Funding Information:
Leta Valentina has received grants from BRC, Parkinson's UK, a travel and congress grant from Bial UK Ltd, speaker‐related activities fees from Britannia pharmaceuticals, and consultancy fees from Invisio Pharmaceuticals, outside the submitted work.
Funding Information:
Rukavina Katarina is supported by NIHR BRC.
Funding Information:
Grigoriou Sotirios has received academic grants from: Multipark, Elsa Schmitz foundation and O Stoltz foundation.
Funding Information:
Odin Per has acted on advisory board for AbbVie, GKC, Bial, Lobsor, Zambon, and Britannia, and has received honoraria for lectures from AbbVie, Britannia, UCB, Zambon, and grants (Investigator Initiated) from AbbVie. Academic grants: Swedish Parkinson Foundation, Lund Medical Faculty, Region Skåne, Åhlens foundation.
Funding Information:
Chaudhuri K. Ray has acted on advisory board for AbbVie, UCB, GKC, Bial, Cynapsus, Novartis, Lobsor, Stada, Medtronic, Zambon, Profile, Sunovion, Roche, Therevance, Scion and Britannia, and has received honoraria for lectures from AbbVie,Britannia, UCB, Mundipharma, Zambon, Novartis, Boeringer Ingelheim, and grants (Investigator Initiated) from Britania Pharmaceuticals, AbbVie, UCB, GKC, Bial, Academic grants: EU, IMI EU, Horizon 2020, Parkinson's UK, NIHR, PDNMG, EU (Horizon 2020), Kirby Laing Foundation, NPF, MRC, Welcome Trust.
Publisher Copyright:
© 2021 The Authors. Brain and Behavior published by Wiley Periodicals LLC
PY - 2021/10
Y1 - 2021/10
N2 - Background: Non-motor symptoms (NMS) are integral to Parkinson's Disease (PD) and management remains a challenge. Safinamide is a novel molecule in relation to addressing NMS due to its multifocal mechanism of action with both dopaminergic and non-dopaminergic properties. Objective: To investigate the efficacy of safinamide on NMS and its burden in PD patients with motor fluctuations after 6 months of treatment. Methods: This observational, multicenter, open-label, pilot study assessed a wide range of NMS using the following rating scales, NMSS (non-motor symptom scale), KPPS (King's PD pain scale), HADS (hospital anxiety and depression scale), PDQ-8 (Parkinson's disease quality of life questionnaire), and PDSS-2 (Parkinson's disease sleep scale), EuroQol-5D 3 level version (EQ-5D-3L), CGI-I (clinical global impression of improvement), and PGI-C (patient global impression of change). Motor examination using UPDRS part III (Unified Parkinson's disease rating scale, motor examination), UPDRS IV (complications of therapy) and Hoehn and Yahr staging were also obtained. Results: 27 patients were included in the analysis and were evaluated at baseline and ≥ 6 months after safinamide treatment. 26 patients had a daily maintenance dose of 100 mg and 1 patient a daily dose of 50 mg. Significant improvements in UPDRS IV, KPPS item 5 (region-specific “off” dystonia), KPPS domain 3 (items 4–6, fluctuation related pain) and KPPS total score were observed after treatment with safinamide, while maintaining stable dopaminergic medication. No statistically significant differences were found in NMSS, HADS, PDSS-2, EQ-5D-3L, and PDQ-8 after treatment. Conclusions: Our results suggest that safinamide may have a beneficial effect on pain, a key unmet need in fluctuating PD patients.
AB - Background: Non-motor symptoms (NMS) are integral to Parkinson's Disease (PD) and management remains a challenge. Safinamide is a novel molecule in relation to addressing NMS due to its multifocal mechanism of action with both dopaminergic and non-dopaminergic properties. Objective: To investigate the efficacy of safinamide on NMS and its burden in PD patients with motor fluctuations after 6 months of treatment. Methods: This observational, multicenter, open-label, pilot study assessed a wide range of NMS using the following rating scales, NMSS (non-motor symptom scale), KPPS (King's PD pain scale), HADS (hospital anxiety and depression scale), PDQ-8 (Parkinson's disease quality of life questionnaire), and PDSS-2 (Parkinson's disease sleep scale), EuroQol-5D 3 level version (EQ-5D-3L), CGI-I (clinical global impression of improvement), and PGI-C (patient global impression of change). Motor examination using UPDRS part III (Unified Parkinson's disease rating scale, motor examination), UPDRS IV (complications of therapy) and Hoehn and Yahr staging were also obtained. Results: 27 patients were included in the analysis and were evaluated at baseline and ≥ 6 months after safinamide treatment. 26 patients had a daily maintenance dose of 100 mg and 1 patient a daily dose of 50 mg. Significant improvements in UPDRS IV, KPPS item 5 (region-specific “off” dystonia), KPPS domain 3 (items 4–6, fluctuation related pain) and KPPS total score were observed after treatment with safinamide, while maintaining stable dopaminergic medication. No statistically significant differences were found in NMSS, HADS, PDSS-2, EQ-5D-3L, and PDQ-8 after treatment. Conclusions: Our results suggest that safinamide may have a beneficial effect on pain, a key unmet need in fluctuating PD patients.
KW - glutamate
KW - MAO-B inhibitor
KW - non-motor symptoms
KW - pain
KW - Parkinson's disease
KW - safinamide
UR - http://www.scopus.com/inward/record.url?scp=85114086799&partnerID=8YFLogxK
U2 - 10.1002/brb3.2336
DO - 10.1002/brb3.2336
M3 - Article
C2 - 34478245
AN - SCOPUS:85114086799
SN - 2162-3279
VL - 11
JO - Brain and Behavior
JF - Brain and Behavior
IS - 10
M1 - e2336
ER -