Neuropathic Pain Clinical Trial
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
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
| Status | Completed |
| Enrollment | 272 |
| Est. completion date | |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Austria | Universitatsklinik Fur Neurologie | Graz | |
| Austria | Universitatsklinik Fur Neurologie | Innsbruck | |
| Austria | LKH | Klagenfurt | |
| Austria | General Hospital AKH | Wien | |
| Czech Republic | Fakultni nemocnice u svate' Anny v Brne | Brno | |
| Czech Republic | Fakultni nemocnice Brno | Brno-Bhunice | |
| Czech Republic | University Hospital Olomouc | Olomouc | |
| Czech Republic | Univercity Hospital Pilsen | Pizen | |
| Czech Republic | Na Homolce Hospital | Prague | |
| Czech Republic | Fakultni Thomayerova nemocnices poliklinikou | Praha | |
| India | Neurology Centre | Ahmedabad | |
| India | M.S. Ramaiah Medical | Bangalore | |
| India | R.S. R'S Trinity Acute Care Hospital | Chennai | |
| India | Sri Ramachandra medical College | Chennai | |
| India | Care Hospital | Hyderabad | |
| India | Chowpatty Medical Centre | Mumbai | |
| India | Brain and Mind Institute | Nagpur | |
| India | Apollo Hospital | Pradesh | |
| India | Brain Waves Clinic | Pune | |
| India | Vijaya Health Centre | Vadapalani | |
| Italy | Ospedali Riuniti di Bergamo | Bergamo | |
| Italy | Ce. S.I. Fondazione Universitaria | Chieti | |
| Italy | Ospedale Clinicizzato Universitario SS. Annunziata | Chieti | |
| Italy | Arcispedale Sant'Anna | Ferrara | |
| Italy | Azienda Ospedaliera San Martino | Genova | |
| Italy | Universita degli Studi di Genova | Genova | |
| Italy | Ospedale Luigi Sacco | Grassi | |
| Italy | Ospedale Civile Umberto I | Mestre | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Istituto Scientifico di Riabilazione di Montescano | Montescano | |
| Italy | Policlinico Universitario Federico II | Napoli | |
| Italy | UCADH | Pavia | |
| Italy | Presidio Ospedaliero Monteluce | Perugia | |
| Italy | Universita degli Studi di Roma | Roma | |
| Italy | Policlinico G.B. Rossi | Verona | |
| Poland | Centrum Medyczne Osteomed | Bialobrzeska | |
| Poland | Centrum Kliniczno Badawcze | Elblag | |
| Poland | Wojewodzki Szpiyal Spejalistyczny | Gdansk | |
| Poland | Center Of Clinical Neurology | Krakow | |
| Poland | Osrodek Baden Klinicznych | Lublin | |
| Poland | Wojskowy Instytut Medyczny | Warszawa | |
| Poland | Wroclaw Medical University | Wroclaw | |
| Poland | Oddzial Neurologiczny | Zgierz | |
| United Kingdom | Gartnavel General Hospital | Glasgow | |
| United Kingdom | Barta and The London NHS Trust | London | |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Solihull Hospital | West Midlands |
| Lead Sponsor | Collaborator |
|---|---|
| Newron |
Austria, Czech Republic, India, Italy, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of pain intensity | Baseline to week 8 or last visit | No | |
| Secondary | The incidence of adverse events | From baseline to week 8 or last visit | No |
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