Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable dose of levodopa.

Conditions

• Parkinson's Disease

Interventions

DRUG

Safinamide

DRUG

Safinamide

DRUG

Placebo

Sponsors & Collaborators

• Newron Pharmaceuticals SPA

  lead INDUSTRY

Principal Investigators

• Mohit Bhatt, MD · Jaslok Hospital, Mumbai

• Neeta Mehta, MD · J.J Hospital, Mumbai

• Sankhla Charulata, MD · P.D. Hinduja Hospital, Mumbai

• Ajit Sowani, MD · Neurology Centre, Ahmedabad

• Prosenjit Chakraborty, MD · Roby General Hospital, Kolkata

• Sudhir Kothari, MD · Poona Hospital, Pune

• Sunil Bandishti, MD · Ruby Hall Clinic, Pune

• CU Velmurugendran, MD · Sri Ramachandra Medical College, Chennai

• Suresh Kumar, MD · Vijaya Health Centre, Chennai

• Devanathan Vasudevan, MD · Kamakshi Memorial Hospital, Chennai

• Rupam Borgohain, MD · Nizams Institute of Medical Sciences, Hyderabad

• J.K Murthy, MD · CARE Hospital, Hyderabad

• Vavilikolanu Prasad, MD · Owasis Hospital & Research Centre, Hyderabad

• Subashini Prabhakar, MD · Spectra Clinical Research Centre, Hyderabad

• Keshava Belur, MD · J.S.S. Hospital Agrahara, Mysore

• Pramod Pal, MD · NIMHANS, Bangalore

• Ajit Kumar Roy, MD · St. Johns Medical College and Hospital, Bangalore

• Rangashetti Srinivasa, MD · M.S. Ramaiah Memoria Hospital, Bangalore

• Arun B Shah, MD · T.N.M.C and B.Y.L Nair Hospital, Mumbai

• Krishnan Vijayan, MD · Kovai Medical Centre and Hospital, Coimbatore

• Neeta Mehta, MD · Neeta Mehta's Clinic, Mumbai

• Chandrashekhar Meshram, MD · Brain and Mind Institute, Nagpur

• Nellikunja Shankar, MD · Mallikatta Neuro and Research Centre, Mangalore

• Asha Kishore, MD · Sree Chitra Tirual Institute for Sciences and Technology, Kerela

• Ummer Karadan, MD · Baby Memorial Hospital, Calicut

• Mohammad I Sahadulla, MD · Kerala Institute of Medical Sciences, Trivandrum

• Madhuri Behari, MD · All India Institute of Medical Sciences

• Prahlad K Sethi, MD · Sir Ganga Ram Hospital, New Delhi

• Shamsher Dwivedee, MD · Vidyasagar Institute of Mental Health and Neurosciences, New Delhi

• Mukul Varma, MD · Indraprastha Apollo Hospital, New Delhi

• Rajinder Bansal, MD · Dayanand Medical College and Hospital, Ludhiana

• Sudesh Prabhakar, MD · Post Grad Institute of Medical Education,& Research Dept of Neurology, Chandigarh

• Sunil Pradhan, MD · Institute of Human Behaviour and Allied Sciences, Dilshad Garden Delhi

• Rakesh Shukla, MD · Chhatrapati Sahuji Maharaj Medical University, Lucknow

• Pahari Ghosh, MD · Sri Aurbindo Seva Kendra, Kolkata

• Ovidiu Bajenaru, MD · University Hospital of Emergency Hospital, Bucuresti

• Cristina Panea, MD · Elias University Hospital, Bucuresti

• Ana Campeanu, MD · Fundeni Hospital, Bucuresti

• Marina Ticmeanu, MD · colentina Hospital, Bucuresti

• Dafin Muresanu, MD · Emergency Hospital Cluj, Cluj

• Angelo Bulboaca, MD · Rehabilitation Hospital Cluj, Cluj

• Jozsef Szasz, MD · Emergency Hospital Targu-Mures, Targu Mures

• Cristian Dinu Popescu, MD · Rehabiliation Hospital Iasi, Iasi

• Mihaela Simu, MD · Emergency Hospital Timisoara no. 1, Timisoara

• Dana Chirileanu, MD · Emergency Hospital Timisoara no.1, Timisoara

• Roberto Eleopra, MD · Ospedale dell'Angelo, Venezia

• Rocco Quatrale, MD · Arcispedale S. Anna, Ferrara

• Marco Onofri, MD · Centro dell'invecchiamento, Chieti

• Tanina Pia Avarello, MD · Centro di Riferimento Regionale Malattie Extra Piramidali, Palermo

• Ubaldo Bonuccelli, MD · Ospedale di Viareggio, Viareggio

• Giovanni Fabbrini, MD · Dip. Scienze Neurologiche, Roma

• Paolo Stanzione, MD · University of Rome Tor Vergata

• Fabrizio Stocchi, MD · IRCCS S. Raffaele Pisana, Roma

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2008-10-31

Completion

2009-02-28