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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

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ClinicalTrials.gov Identifier: NCT00643045
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : March 25, 2008
Sponsor:
Information provided by:
Newron Pharmaceuticals SPA

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: Safinamide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Safinamide

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



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

Secondary Outcome Measures :
  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 [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643045


Sponsors and Collaborators
Newron Pharmaceuticals SPA
Investigators
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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
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Responsible Party: Dr Stefano Rossetti, Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier: NCT00643045    
Other Study ID Numbers: NW 1015/015/III/2003
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008
Keywords provided by Newron Pharmaceuticals SPA:
Parkinson Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases