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

NCT ID: NCT00643045

Last Updated: 2008-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Parkinson's Disease

Keywords

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Low dose (50-100mg/day)

Group Type EXPERIMENTAL

Safinamide

Intervention Type DRUG

2

High dose (150-200 mg/day)

Group Type EXPERIMENTAL

Safinamide

Intervention Type DRUG

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Safinamide

Intervention Type DRUG

Safinamide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role lead

Responsible Party

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Newron Pharmaceuticals S.p.A.

Principal Investigators

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Marcelo Merello, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto FLENI, Buenos Aires

Rolando Giannaula, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Español - Servicio de Neurologia, Buenos Aires

Federico Micheli, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas, Servicio de Movimientos, Buenos Aires

Marcelo Miranda, MD

Role: PRINCIPAL_INVESTIGATOR

Liga Chilena Contra el Mal De Parkinson, Santiago, Chile

David Saez, MD

Role: PRINCIPAL_INVESTIGATOR

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

Roque Villagra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Salvador-Neurologia, Santiago, Chile

Yuri Takeuchi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Mauricio Acevedo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Pablo Lorenzana, MD

Role: PRINCIPAL_INVESTIGATOR

Consultorio, Bogotà-D.C, Colombia

Madhuri Behari, MD

Role: PRINCIPAL_INVESTIGATOR

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

Mohit Bhatt, MD

Role: PRINCIPAL_INVESTIGATOR

Movement Disorder Clinic, Jaslok Hospital, Mumbai, India

Rupam Borgohain, MD

Role: PRINCIPAL_INVESTIGATOR

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

Arunkumar Shah, MD

Role: PRINCIPAL_INVESTIGATOR

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

Ajit Roy, MD

Role: PRINCIPAL_INVESTIGATOR

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

Uday Babu Rao Muthane, MD

Role: PRINCIPAL_INVESTIGATOR

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

Fabrizio Stocchi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy

Leonardo Scarzelia, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Evangelico Valdese, Torino, Italy

Gianpietro Nodera, MD

Role: PRINCIPAL_INVESTIGATOR

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

Pezzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy

Leontino Battistin, MD

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Neuroscienze, Padova, Italy

Marco Onofri, MD

Role: PRINCIPAL_INVESTIGATOR

Divisione di Neurologia, Ospedale civile di Pescara, Italy

Paolo Lamberti, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Neurologica I Policinico di Bari, Italy

Alessandra Monge, MD

Role: PRINCIPAL_INVESTIGATOR

Osp. S. Giovanni Battista, Roma, Italy

Paolo Barone, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

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

Giovanni Abruzzese, MD

Role: PRINCIPAL_INVESTIGATOR

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

Roberto Marconi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale della Misericordia, Grosseto, Italy

Kulisevsky, MD

Role: PRINCIPAL_INVESTIGATOR

Serv. Neurologia, Barcelona, Spain

Lopez Lozano, MD

Role: PRINCIPAL_INVESTIGATOR

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

Antonio Vacquez, MD

Role: PRINCIPAL_INVESTIGATOR

H. Clinico San Carlos, Ser. Neurologia, Spain

Schapira, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Royal Free Hospital, UK

Chaudhuri, MD

Role: PRINCIPAL_INVESTIGATOR

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

Barker, MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge Centre for Brain Repair, Cambridge, UK

Other Identifiers

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NW 1015/015/III/2003

Identifier Type: -

Identifier Source: org_study_id