Clinical 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson Disease
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 269
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Instituto FLENI, Buenos Aires
name: Marcelo Merello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Español - Servicio de Neurologia, Buenos Aires
name: Rolando Giannaula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas, Servicio de Movimientos, Buenos Aires
name: Federico Micheli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liga Chilena Contra el Mal De Parkinson, Santiago, Chile
name: Marcelo Miranda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Barros Luco Trudeau, Servicio de Neurologia, Santiago, Chile
name: David Saez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Salvador-Neurologia, Santiago, Chile
name: Roque Villagra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundaciόn Valle de Lili Direcciόn Médica, Cali-Valle, Colombia
name: Yuri Takeuchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Militar, Departamento de Neurología, Bogotà-D.C, Colombia
name: Mauricio Acevedo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultorio, Bogotà-D.C, Colombia
name: Pablo Lorenzana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, All India Institute of Medical Science (AIIMS), New Delhi, India
name: Madhuri Behari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Movement Disorder Clinic, Jaslok Hospital, Mumbai, India
name: Mohit Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India
name: Rupam Borgohain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: B.Y.L. Nair Hospital & T.N. Medical College, Mumbai, India
name: Arunkumar Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St John's Medical College & Hospital, Bangalore, India
name: Ajit Roy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Mental Health and Neuro Sciences, Bangalore, India
name: Uday Babu Rao Muthane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy
name: Fabrizio Stocchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Evangelico Valdese, Torino, Italy
name: Leonardo Scarzelia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Neurologia Casa di Cura "Villa Margherita", Vicenza, Italy
name: Gianpietro Nodera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy
name: Pezzoli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Neuroscienze, Padova, Italy
name: Leontino Battistin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Divisione di Neurologia, Ospedale civile di Pescara, Italy
name: Marco Onofri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Neurologica I Policinico di Bari, Italy
name: Paolo Lamberti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Osp. S. Giovanni Battista, Roma, Italy
name: Alessandra Monge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Scienze Neurologiche, Universita di Napoli Federico II, Naples, Italy
name: Paolo Barone, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dipartimento di Neuroscienze DINOG, Universita degli Studi di Genova, Italy
name: Giovanni Abruzzese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale della Misericordia, Grosseto, Italy
name: Roberto Marconi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Serv. Neurologia, Barcelona, Spain
name: Kulisevsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Puerta de Hierro, Serv. Neurologia, Madrid, Spain
name: Lopez Lozano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Clinico San Carlos, Ser. Neurologia, Spain
name: Antonio Vacquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Royal Free Hospital, UK
name: Schapira, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Day Hospital, Care of the Elderly, Lewisham University Hospital, London, UK
name: Chaudhuri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge Centre for Brain Repair, Cambridge, UK
name: Barker, MD
role: PRINCIPAL_INVESTIGATOR
References: