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

NCT00643045 | Completed Phase 3 DMC

• 1 other identifier: NW 1015/015/III/2003
• Study Type: interventional
• Target: 269
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (1)

• 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

Study Arms (3)

1

EXPERIMENTAL

Low dose (50-100mg/day)

Drug: Safinamide

2

EXPERIMENTAL

High dose (150-200 mg/day)

Drug: Safinamide

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Safinamide DRUG

1

Placebo DRUG

3

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 25, 2008
• Study Start: December 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: July 1, 2007
• Last Updated: March 25, 2008

Record last verified: 2008-03