Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Summary

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.

Conditions

• Idiopathic Parkinson's Disease

Interventions

DRUG

Safinamide

DRUG

Safinamide

DRUG

Placebo

Sponsors & Collaborators

• Newron Pharmaceuticals SPA

  lead INDUSTRY

Principal Investigators

• Marcelo Merello, MD · Instituto FLENI, Buenos Aires

• Rolando Giannaula, MD · Hospital Español - Servicio de Neurologia, Buenos Aires

• Federico Micheli, MD · Hospital de Clinicas, Servicio de Movimientos, Buenos Aires

• Marcelo Miranda, MD · Liga Chilena Contra el Mal De Parkinson, Santiago, Chile

• David Saez, MD · Hospital Barros Luco Trudeau, Servicio de Neurologia, Santiago, Chile

• Roque Villagra, MD · Hospital Salvador-Neurologia, Santiago, Chile

• Yuri Takeuchi, MD · Fundaciόn Valle de Lili Direcciόn Médica, Cali-Valle, Colombia

• Mauricio Acevedo, MD · Hospital Militar, Departamento de Neurología, Bogotà-D.C, Colombia

• Pablo Lorenzana, MD · Consultorio, Bogotà-D.C, Colombia

• Madhuri Behari, MD · Department of Neurology, All India Institute of Medical Science (AIIMS), New Delhi, India

• Mohit Bhatt, MD · Movement Disorder Clinic, Jaslok Hospital, Mumbai, India

• Rupam Borgohain, MD · Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India

• Arunkumar Shah, MD · B.Y.L. Nair Hospital & T.N. Medical College, Mumbai, India

• Ajit Roy, MD · St John's Medical College & Hospital, Bangalore, India

• Uday Babu Rao Muthane, MD · National Institute of Mental Health and Neuro Sciences, Bangalore, India

• Fabrizio Stocchi, MD · IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy

• Leonardo Scarzelia, MD · Ospedale Evangelico Valdese, Torino, Italy

• Gianpietro Nodera, MD · Dipartimento di Neurologia Casa di Cura "Villa Margherita", Vicenza, Italy

• Pezzoli, MD · Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy

• Leontino Battistin, MD · Dipartimento di Neuroscienze, Padova, Italy

• Marco Onofri, MD · Divisione di Neurologia, Ospedale civile di Pescara, Italy

• Paolo Lamberti, MD · Clinica Neurologica I Policinico di Bari, Italy

• Alessandra Monge, MD · Osp. S. Giovanni Battista, Roma, Italy

• Paolo Barone, Prof, MD · Dipartimento di Scienze Neurologiche, Universita di Napoli Federico II, Naples, Italy

• Giovanni Abruzzese, MD · Dipartimento di Neuroscienze DINOG, Universita degli Studi di Genova, Italy

• Roberto Marconi, MD · Ospedale della Misericordia, Grosseto, Italy

• Kulisevsky, MD · Serv. Neurologia, Barcelona, Spain

• Lopez Lozano, MD · H. Puerta de Hierro, Serv. Neurologia, Madrid, Spain

• Antonio Vacquez, MD · H. Clinico San Carlos, Ser. Neurologia, Spain

• Schapira, Prof, MD · Department of Neurology, Royal Free Hospital, UK

• Chaudhuri, MD · Day Hospital, Care of the Elderly, Lewisham University Hospital, London, UK

• Barker, MD · Cambridge Centre for Brain Repair, Cambridge, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-12-31

Primary Completion

2006-01-31

Completion

2007-07-31