Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations

Movement Disorders

Volumn 29, Issue 2, 2014, Pages 229-237

  Borgohain, Rupam ^a   Szasz, J ^b   Stanzione, P ^c   Meshram, C ^d   Bhatt, M ^e   Chirilineau, D ^f   Stocchi, F ^g   Lucini, V ^h   Giuliani, R ^h   Forrest, E ^h   Rice, P ⁱ   Anand, R ^j   Illiyas Sahadulla, M ^k   Kardan, U ^k   Keshava, B S ^k   Kishore, A ^k   Kothari, S S ^k   Krishna Murthy, J M ^k   Kumar, S ^k   Kumar Pal, P ^k   Mehta, N ^k   Prabhakar, S ^k   Prabhakar, S Kr ^k   Pradhan, S ^k   Roy, A K ^k   Sankhla, C ^k   Sethi, P K ^k   Shah, A B ^k   Shankar, N ^k   Shukla, R ^k   Sowani, A ^k   Srinivasa, R ^k   Varma, M ^k   Vasudevan, D ^k   Vavilikolanu Sreenivas, P ^k   Velmurugendran, C U ^k   Vijayan, K ^k   Bajenaru, O ^k   Bulboaca, A ^k   Campeanu, A ^k   Chirileanu, D ^k   Muresanu, D ^k   Panea, C ^k   Popescu, C ^k   Simu, M ^k   Ticmeanu, M ^k   Avarello, T ^k   Bonuccelli, U ^k   Eleopra, R ^k   Onofrj, M ^k   Quatrale, R ^k   more..

^a NIZAM'S INSTITUTE OF MEDICAL SCIENCES   (India)

^b UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^c IRCCS FONDAZIONE SANTA LUCIA   (Italy)

^d Brain and Mind Institute   (India)

^e Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute   (India)

^f VICTOR BABES UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^g IRCCS SAN RAFFAELE PISANA   (Italy)

^h Newron Pharmaceuticals SpA   (Italy)

ⁱ Premier Research   (United States)

^j APC AG   (Switzerland)

^k NONE

more..

Author keywords

Dyskinesia; MAO B inhibitor; Safinamide

Indexed keywords

DYSKINESIA; MAO-B INHIBITOR; SAFINAMIDE;

ACTIVITIES OF DAILY LIVING; AGED; ALANINE; ANTIPARKINSON AGENTS; BENZYLAMINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEVODOPA; MALE; MIDDLE AGED; MOTOR ACTIVITY; PARKINSON DISEASE; SEVERITY OF ILLNESS INDEX;

EID: 84894251130     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.25751     Document Type: Article

References (31)

1. LeWitt PA. Levodopa therapeutics for Parkinson's disease: new developments. Parkinsonism Relat Disord 2009;15(Suppl 1):S31-S34.
2. Hauser RA. Levodopa: past, present, and future. Eur Neurol 2009;62:1-8.
3. Hinson VK. Parkinson's disease and motor fluctuations. Curr Treat Options Neurol 2010;12:186-199.
4. Horstink M, Tolosa E, Bonuccelli U, et al. Review of the therapeutic management of Parkinson's disease. Report of a joint task force of the European Federation of Neurological Societies (EFNS) and the Movement Disorder Society-European Section (MDS-ES). Part II: late (complicated) Parkinson's disease. Eur J Neurol 2006;13:1186-1202.
5. Blandini F, Porter RH, Greenamyre JT. Glutamate and Parkinson's disease. Mol Neurobiol 1996;12:73-94.
6. Chase TN, Bibbiani F, Oh JD. Striatal glutamatergic mechanisms and extrapyramidal movement disorders. Neurotox Res 2003;5:139-146.
7. Pevarello P, Bonsignori A, Dostert P, et al. Synthesis and anticonvulsant activity of a new class of 2-[(arylalky)amino]alkanamide derivatives. J Med Chem 1998;41:579-590.
8. Caccia C, Maj R, Calabresi M, et al. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology 2006;67(7 Suppl 2):S18-S23.
9. Caccia C, Salvati P, Rossetti S, Anand R. Safinamide: beyond MAO-B inhibition. Parkinsonism Relat Disord 2007;13(Suppl 2):S99.
10. Chazot PL. Safinamide for the treatment of Parkinson's disease, epilepsy and restless legs syndrome. Curr Opin Investig Drugs 2007;8:570-579.
11. Grégoire L, Jourdain VA, Townsend M, Roach A, Di Paolo T. Safinamide reduces dyskinesias and prolongs l-DOPA antiparkinsonian effect in parkinsonian monkeys. Parkinsonism Relat Disord 2013;19:508-514.
12. Goetz CG, Stebbins GT, Shale HM, et al. Utility of an objective dyskinesia rating scale for Parkinson's disease: inter- and intrarater reliability assessment. Mov Disord 1994;9:390-394.
13. Hauser RA, Friedlander J, Zesiewicz TA, et al. A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol 2000;23:75-81.
14. Hauser RA, Deckers F, Lehert P. Parkinson's disease home diary: further validation and implications for clinical trials. Mov Disord 2004;19:1409-1413.
15. Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol 2005;62:241-248.
16. Chapuis S, Ouchchane L Metz O, Gerbaud L Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord 2005;20:224-230.
17. Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol 2010;67:64-70.
18. Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double- blind, parallel-group trial. Lancet 2005;365:947-954.
19. Gregoire L, Roach A, Di Paolo T. Safinamide reduces levodopa-induced dyskinesia in MPTP-lesioned primates while prolonging anti-parkinsonian efficacy. Mov Disord 2010;25(Suppl 2):S411.
20. Arpinelli F, Bamfi F. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company. Health Qual Life Outcomes 2006;4:85.
21. Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol 2008;60:57-66.
22. Schapira AH, Fox S, Hauser R, et al. SETTLE: a study design: 24-week, double- blind, placebo-controlled study of the efficacy and safety of safinamide as add-on therapy to levodopa in patients with Parkinson's Disease. Mov Disord 2010;25(Suppl 2):S308.
23. Stocchi F, Vacca L, Grassini P, De Pandis MF, Battaglia G, Cattaneo C, Fariello RG. Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition. Neurology 2006;67:S24-S29.
24. Stocchi F, Arnold G, Onofrj M, et al. Improvement of motor function in early Parkinson disease by safinamide. Neurology 2004;63:746-748.
25. Borgohain R, Bhatt M, Rossetti S, Anand R. Safinamide potentiates the effects of dopamine (DA)-agonists in early stage Parkinson's disease patients. Parkinsonism Relat Disord 2007;13(Suppl 2):S99.
26. Stocchi F, Borgohain R, Onofrj M, et al. Safinamide, a new anti-parkinson agent is effective and well-tolerated in early PD patients on a stable dose of a single DA- agonist: Results of a randomized, international, placebo-controlled Phase III trial. Neurology 2007;68(12 Suppl 1):A109.
27. Anand R, Lucini V, Giuliani R, Rossetti S. Long-term double-blind, placebo-controlled evaluation of the safety and efficacy of safinamide as an add-on to stable dopamine agonist therapy in patients with Parkinson's disease. Parkinsonism Relat Disord 2007;13(Suppl 2):S99-S100.
28. Schapira AH, Borgohain R, Stocchi F, et al.; Study Investigators. Long-term safety and efficacy of safinamide added to dopamine agonists in early Parkinson's disease (PD). Neurology 2008;70(11 Suppl 1):A424.
29. Barone P, Fernandez J, Ferreira JJ, et al. MOTION (safinaMide add-On To dopamine agonist in early Idiopathic ParkinsON's disease) study design: a 24 week, double-blind, placebo-controlled study of the efficacy and safety of safinamide. Mov Disord 2010;25(Suppl 2):S289.
30. Stocchi F, Borgohain R, Onofrj M, et al. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients. Mov Disord 2012;27:106-112.
31. Schapira AH, Stocchi F, Borgohain R, et al. Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease. Eur J Neurol 2013;20:271-280.