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To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine agonist. It is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low dose (50-100mg/day) |
|
| 2 | Experimental | High dose (150-200 mg/day) |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safinamide | Drug |
| ||
| Safinamide |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS Section III (ME) item (& total) scores.CGI Change from Baseline score.UPDRS Section II (ADL) item (& total) scores.CGI Severity of Illness score. H&Y Staging.All above at each visit and Endpoint (LOCF). Cogtest PD battery score each visit | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Merello, MD | Instituto FLENI, Buenos Aires | Principal Investigator |
| Rolando Giannaula, MD | Hospital Español - Servicio de Neurologia, Buenos Aires | Principal Investigator |
| Federico Micheli, MD | Hospital de Clinicas, Servicio de Movimientos, Buenos Aires | Principal Investigator |
| Marcelo Miranda, MD | Liga Chilena Contra el Mal De Parkinson, Santiago, Chile | Principal Investigator |
| David Saez, MD | Hospital Barros Luco Trudeau, Servicio de Neurologia, Santiago, Chile | Principal Investigator |
| Roque Villagra, MD | Hospital Salvador-Neurologia, Santiago, Chile | Principal Investigator |
| Yuri Takeuchi, MD | Fundaciόn Valle de Lili Direcciόn Médica, Cali-Valle, Colombia | Principal Investigator |
| Mauricio Acevedo, MD | Hospital Militar, Departamento de NeurologÃa, Bogotà -D.C, Colombia | Principal Investigator |
| Pablo Lorenzana, MD | Consultorio, Bogotà -D.C, Colombia |
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|
| Placebo | Drug |
|
| Principal Investigator |
| Madhuri Behari, MD | Department of Neurology, All India Institute of Medical Science (AIIMS), New Delhi, India | Principal Investigator |
| Mohit Bhatt, MD | Movement Disorder Clinic, Jaslok Hospital, Mumbai, India | Principal Investigator |
| Rupam Borgohain, MD | Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India | Principal Investigator |
| Arunkumar Shah, MD | B.Y.L. Nair Hospital & T.N. Medical College, Mumbai, India | Principal Investigator |
| Ajit Roy, MD | St John's Medical College & Hospital, Bangalore, India | Principal Investigator |
| Uday Babu Rao Muthane, MD | National Institute of Mental Health and Neuro Sciences, Bangalore, India | Principal Investigator |
| Fabrizio Stocchi, MD | IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy | Principal Investigator |
| Leonardo Scarzelia, MD | Ospedale Evangelico Valdese, Torino, Italy | Principal Investigator |
| Gianpietro Nodera, MD | Dipartimento di Neurologia Casa di Cura "Villa Margherita", Vicenza, Italy | Principal Investigator |
| Pezzoli, MD | Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy | Principal Investigator |
| Leontino Battistin, MD | Dipartimento di Neuroscienze, Padova, Italy | Principal Investigator |
| Marco Onofri, MD | Divisione di Neurologia, Ospedale civile di Pescara, Italy | Principal Investigator |
| Paolo Lamberti, MD | Clinica Neurologica I Policinico di Bari, Italy | Principal Investigator |
| Alessandra Monge, MD | Osp. S. Giovanni Battista, Roma, Italy | Principal Investigator |
| Paolo Barone, Prof, MD | Dipartimento di Scienze Neurologiche, Universita di Napoli Federico II, Naples, Italy | Principal Investigator |
| Giovanni Abruzzese, MD | Dipartimento di Neuroscienze DINOG, Universita degli Studi di Genova, Italy | Principal Investigator |
| Roberto Marconi, MD | Ospedale della Misericordia, Grosseto, Italy | Principal Investigator |
| Kulisevsky, MD | Serv. Neurologia, Barcelona, Spain | Principal Investigator |
| Lopez Lozano, MD | H. Puerta de Hierro, Serv. Neurologia, Madrid, Spain | Principal Investigator |
| Antonio Vacquez, MD | H. Clinico San Carlos, Ser. Neurologia, Spain | Principal Investigator |
| Schapira, Prof, MD | Department of Neurology, Royal Free Hospital, UK | Principal Investigator |
| Chaudhuri, MD | Day Hospital, Care of the Elderly, Lewisham University Hospital, London, UK | Principal Investigator |
| Barker, MD | Cambridge Centre for Brain Repair, Cambridge, UK | Principal Investigator |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C092797 | safinamide |
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