Clinical trial NCT00736151: Phase II Dose Titration Study in Patients With Neuropathic Pain
Official title: A Phase II, Multicentre, Pilot, Randomised, Double Blind Placebo Controlled Dose Titration Study to Evaluate the Safety, Maximum Tolerated Dose and Preliminary Evidence of Efficacy of Orally Administered Ralfinamide at Four Doses (80, 160, 240 and 320 mg/Day) in Patients With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Male or female patients
* Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
* Diagnosed by neurologist with current neuropathic pain

Exclusion Criteria:

* See inclusion criteria

Primary outcomes:
measure: Change of pain intensity
timeFrame: Baseline to week 8 or last visit
Secondary outcomes:
measure: The incidence of adverse events
timeFrame: From baseline to week 8 or last visit
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitatsklinik Fur Neurologie
city: Innsbruck
country: Austria
facility: Universitatsklinik Fur Neurologie
city: Klagenfurt
country: Austria
facility: LKH
city: Wien
country: Austria
facility: General Hospital AKH
city: Brno-Bhunice
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u svate' Anny v Brne
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Pizen
country: Czech Republic
facility: Univercity Hospital Pilsen
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
city: Praha
country: Czech Republic
facility: Fakultni Thomayerova nemocnices poliklinikou
city: Ahmedabad
country: India
facility: Neurology Centre
city: Bangalore
country: India
facility: M.S. Ramaiah Medical
city: Chennai
country: India
facility: R.S. R'S Trinity Acute Care Hospital
city: Chennai
country: India
facility: Sri Ramachandra medical College
city: Hyderabad
country: India
facility: Care Hospital
city: Mumbai
country: India
facility: Chowpatty Medical Centre
city: Nagpur
country: India
facility: Brain and Mind Institute
city: Pradesh
country: India
facility: Apollo Hospital
city: Pune
country: India
facility: Brain Waves Clinic
city: Vadapalani
country: India
facility: Vijaya Health Centre
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Chieti
country: Italy
facility: Ce. S.I. Fondazione Universitaria
city: Chieti
country: Italy
facility: Ospedale Clinicizzato Universitario SS. Annunziata
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Genova
country: Italy
facility: Universita degli Studi di Genova
city: Grassi
country: Italy
facility: Ospedale Luigi Sacco
city: Mestre
country: Italy
facility: Ospedale Civile Umberto I
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Montescano
country: Italy
facility: Istituto Scientifico di Riabilazione di Montescano
city: Napoli
country: Italy
facility: Policlinico Universitario Federico II
city: Pavia
country: Italy
facility: UCADH
city: Perugia
country: Italy
facility: Presidio Ospedaliero Monteluce
city: Roma
country: Italy
facility: Universita degli Studi di Roma
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
city: Bialobrzeska
country: Poland
facility: Centrum Medyczne Osteomed
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdansk
country: Poland
facility: Wojewodzki Szpiyal Spejalistyczny
city: Krakow
country: Poland
facility: Center Of Clinical Neurology
city: Lublin
country: Poland
facility: Osrodek Baden Klinicznych
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
city: Zgierz
country: Poland
facility: Oddzial Neurologiczny
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: London
country: United Kingdom
facility: Barta and The London NHS Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: West Midlands
country: United Kingdom
facility: Solihull Hospital
Study officials:
References: