A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients

Movement Disorders

Volumn 27, Issue 1, 2012, Pages 106-112

  Stocchi, Fabrizio ^a   Borgohain, Rupam ^b   Onofrj, Marco ^c   Schapira, Anthony H V ^d   Bhatt, Mohit ^e   Lucini, Valentina ^f   Giuliani, Rodolfo ^f   Anand, Ravi ^g  

^a IRCCS SAN RAFFAELE PISANA   (Italy)

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

^c UNIVERSITY OF CHIETI   (Italy)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e Movement Disorder Clinic   (India)

^f Newron Pharmaceuticals   (Italy)

^g APC ^*  (Switzerland)

Author keywords

aminoamide; Add on; Dopamine; Motor function; Parkinson's disease; Safinamide

Indexed keywords

AMANTADINE; BROMOCRIPTINE; CABERGOLINE; LISURIDE; PERGOLIDE; PIRIBEDIL; PLACEBO; PRAMIPEXOLE; ROPINIROLE; SAFINAMIDE;

ABDOMINAL PAIN; ADD ON THERAPY; ADULT; AGED; ARTICLE; BACKACHE; BLURRED VISION; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GASTRITIS; GASTROESOPHAGEAL REFLUX; HUMAN; HYPERTENSION; HYPOTENSION; IRON DEFICIENCY ANEMIA; LEG PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA AND VOMITING; PARESTHESIA; PARKINSON DISEASE; PERIPHERAL EDEMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINA VEIN OCCLUSION; RHINOPHARYNGITIS; TREMOR; UNIFIED PARKINSON DISEASE RATING SCALE;

ADULT; AGED; AGED, 80 AND OVER; ALANINE; ANALYSIS OF VARIANCE; ANTIPARKINSON AGENTS; BENZYLAMINES; DOPAMINE AGONISTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERNATIONAL COOPERATION; MALE; MIDDLE AGED; PARKINSON DISEASE; RETROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX;

EID: 84855957418     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.23954     Document Type: Article

References (20)

1. Miyasaki JM, Martin W, Suchowersky O, Weiner WJ, Lang AE. Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2002; 58: 11-17.
2. 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 and the Movement Disorder Society-European Section. Part I: early (uncomplicated) Parkinson's disease. Eur J Neurol 2006; 13: 1170-1185.
3. NICE. Parkinson's disease diagnosis and management in primary and secondary care. 2006. Available at: Accessed on July 2, 2010.
4. Rascol O, Brooks DJ, Korczyn AD, et al. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med 2000; 342: 1484-1491.
5. Holloway RG, Shoulson I, Fahn S, et al. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch Neurol 2004; 61: 1044-1053.
6. Bonuccelli U, Pavese N. Dopamine agonists in the treatment of Parkinson's disease. Expert Rev Neurother 2006; 6: 81-89.
7. Singh A, Kandimala G, Dewey RB, Jr., O'Suilleabhain P. Risk factors for pathologic gambling and other compulsions among Parkinson's disease patients taking dopamine agonists. J Clin Neurosci 2007; 14: 1178-1181.
8. Simuni T, Lyons KE, Pahwa R, et al. Treatment of early Parkinson's disease. Part 2. Eur Neurol 2009; 61: 206-215.
9. Constantinescu R, Romer M, McDermott MP, Kamp C, Kieburtz K. Impact of pramipexole on the onset of levodopa-related dyskinesias. Mov Disord 2007; 22: 1317-1319.
10. Rascol O, Brooks DJ, Korczyn AD, et al. Development of dyskinesias in a 5-year trial of ropinirole and L-dopa. Mov Disord 2006; 21: 1844-1850.
11. 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.
12. Caccia C, Maj R, Calabresi M, et al. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology 2006; 67: S18-S23.
13. Caccia C, Salvati P, Rossetti S, Anand R. Safinamide: beyond MAO-B inhibition. Parkinsonism Relat Disord 2007; 13( Suppl 2): S99.
14. Cattaneo C, Caccia C, Marzo A, Maj R, Fariello RG. Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition. Clin Neuropharmacol 2003; 26: 213-217.
15. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56-62.
16. Lidstone SC, Schulzer M, Dinelle K, et al. Effects of expectation on placebo-induced dopamine release in Parkinson disease. Arch Gen Psychiatry 2010; 67: 857-865.
17. Meissner WG, Frasier M, Gasser T, et al. Priorities in Parkinson's disease research. Nat Rev Drug Discov 2011; 10: 377-393.
18. Stocchi F, Arnold G, Onofrj M, et al. Improvement of motor function in early Parkinson disease by safinamide. Neurology 2004; 63: 746-748.
19. Onofrj M, Bonanni L, Thomas A. An expert opinion on safinamide in Parkinson's disease. Expert Opin Investig Drugs 2008; 17: 1-11.
20. Stocchi F, Rascol O, Kieburtz K, et al. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol 2010; 68: 18-27.