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

A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Safinamide

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3	Drug: Placebo
Experimental: 1; Low dose (50-100mg/day)	Drug: Safinamide
Experimental: 2; High dose (150-200 mg/day)	Drug: Safinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).	24 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Newron Pharmaceuticals SPA
• Investigators: Principal Investigator: 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 Neurología, Bogotà-D.C, Colombia; Principal Investigator: Pablo Lorenzana, MD, Consultorio, Bogotà-D.C, Colombia; 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

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: March 21, 2008
• First Submitted That Met QC Criteria: March 24, 2008
• First Posted (Estimate): March 25, 2008

Study Record Updates

• Last Update Posted (Estimate): March 25, 2008
• Last Update Submitted That Met QC Criteria: March 24, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Parkinson Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NW 1015/015/III/2003