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Search / Trial NCT00643045

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

Launched by NEWRON PHARMACEUTICALS SPA · Mar 24, 2008

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Trial Information

Current as of May 13, 2025

Completed

Keywords

Parkinson Disease

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Patients with a diagnosis of idiopathic Parkinson's disease of less than 5 years duration, and a Hoehn and Yahr Stage of I to III,
  • • who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to Visit 1 (Screening).
  • Exclusion Criteria:
  • • Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
  • • patients with a diagnosis or recent history of substance abuse,
  • • a history of psychosis,
  • • who were depressed,
  • • had evidence of dementia or cognitive dysfunction,
  • • or who were experiencing end of dose wearing-off;
  • • female patients of childbearing potential;
  • • patients who have previously received safinamide.

About Newron Pharmaceuticals Spa

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on the development of innovative therapies for patients with central nervous system (CNS) disorders and pain. Headquartered in Italy, Newron is dedicated to addressing unmet medical needs through advanced research and clinical trials. The company’s pipeline includes a range of novel compounds designed to improve treatment outcomes for conditions such as schizophrenia, Parkinson's disease, and neuropathic pain. With a commitment to excellence in scientific rigor and patient care, Newron Pharmaceuticals aims to enhance the quality of life for individuals affected by debilitating neurological conditions.

Locations

Patients applied

0 patients applied

Trial Officials

Marcelo Merello, MD

Principal Investigator

Instituto FLENI, Buenos Aires

Rolando Giannaula, MD

Principal Investigator

Hospital Español - Servicio de Neurologia, Buenos Aires

Federico Micheli, MD

Principal Investigator

Hospital de Clinicas, Servicio de Movimientos, Buenos Aires

Marcelo Miranda, MD

Principal Investigator

Liga Chilena Contra el Mal De Parkinson, Santiago, Chile

David Saez, MD

Principal Investigator

Hospital Barros Luco Trudeau, Servicio de Neurologia, Santiago, Chile

Roque Villagra, MD

Principal Investigator

Hospital Salvador-Neurologia, Santiago, Chile

Yuri Takeuchi, MD

Principal Investigator

Fundaciόn Valle de Lili Direcciόn Médica, Cali-Valle, Colombia

Mauricio Acevedo, MD

Principal Investigator

Hospital Militar, Departamento de Neurología, Bogotà-D.C, Colombia

Pablo Lorenzana, MD

Principal Investigator

Consultorio, Bogotà-D.C, Colombia

Madhuri Behari, MD

Principal Investigator

Department of Neurology, All India Institute of Medical Science (AIIMS), New Delhi, India

Mohit Bhatt, MD

Principal Investigator

Movement Disorder Clinic, Jaslok Hospital, Mumbai, India

Rupam Borgohain, MD

Principal Investigator

Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India

Arunkumar Shah, MD

Principal Investigator

B.Y.L. Nair Hospital & T.N. Medical College, Mumbai, India

Ajit Roy, MD

Principal Investigator

St John's Medical College & Hospital, Bangalore, India

Uday Babu Rao Muthane, MD

Principal Investigator

National Institute of Mental Health and Neuro Sciences, Bangalore, India

Fabrizio Stocchi, MD

Principal Investigator

IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy

Leonardo Scarzelia, MD

Principal Investigator

Ospedale Evangelico Valdese, Torino, Italy

Gianpietro Nodera, MD

Principal Investigator

Dipartimento di Neurologia Casa di Cura "Villa Margherita", Vicenza, Italy

Pezzoli, MD

Principal Investigator

Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy

Leontino Battistin, MD

Principal Investigator

Dipartimento di Neuroscienze, Padova, Italy

Marco Onofri, MD

Principal Investigator

Divisione di Neurologia, Ospedale civile di Pescara, Italy

Paolo Lamberti, MD

Principal Investigator

Clinica Neurologica I Policinico di Bari, Italy

Alessandra Monge, MD

Principal Investigator

Osp. S. Giovanni Battista, Roma, Italy

Paolo Barone, Prof, MD

Principal Investigator

Dipartimento di Scienze Neurologiche, Universita di Napoli Federico II, Naples, Italy

Giovanni Abruzzese, MD

Principal Investigator

Dipartimento di Neuroscienze DINOG, Universita degli Studi di Genova, Italy

Roberto Marconi, MD

Principal Investigator

Ospedale della Misericordia, Grosseto, Italy

Kulisevsky, MD

Principal Investigator

Serv. Neurologia, Barcelona, Spain

Lopez Lozano, MD

Principal Investigator

H. Puerta de Hierro, Serv. Neurologia, Madrid, Spain

Antonio Vacquez, MD

Principal Investigator

H. Clinico San Carlos, Ser. Neurologia, Spain

Schapira, Prof, MD

Principal Investigator

Department of Neurology, Royal Free Hospital, UK

Chaudhuri, MD

Principal Investigator

Day Hospital, Care of the Elderly, Lewisham University Hospital, London, UK

Barker, MD

Principal Investigator

Cambridge Centre for Brain Repair, Cambridge, UK

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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