Phase II Dose Titration Study in Patients With Neuropathic Pain

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Ralfinamide

• Registration Number: NCT00736151
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2007-04
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ralfinamide	Ralfinamide administered orally at rising doses of 80 - 320 mg/day
2	Ralfinamide	Placebo controlled with randomization of 2:1

Primary Outcome Measures

Name	Time	Method
Change of pain intensity	Baseline to week 8 or last visit

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse events	From baseline to week 8 or last visit

Trial Locations

Locations (46)

Universitatsklinik Fur Neurologie; 🇦🇹 Innsbruck, Austria

Fakultni nemocnice Brno; 🇨🇿 Brno-Bhunice, Czech Republic

Fakultni Thomayerova nemocnices poliklinikou; 🇨🇿 Praha, Czech Republic

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, India

Ce. S.I. Fondazione Universitaria; 🇮🇹 Chieti, 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

Policlinico G.B. Rossi; 🇮🇹 Verona, Italy

Centrum Kliniczno Badawcze; 🇵🇱 Elblag, Poland

Wojewodzki Szpiyal Spejalistyczny; 🇵🇱 Gdansk, Poland

Center Of Clinical Neurology; 🇵🇱 Krakow, Poland

Osrodek Baden Klinicznych; 🇵🇱 Lublin, Poland

Universita degli Studi di Roma; 🇮🇹 Roma, Italy

Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Poland

Wroclaw Medical University; 🇵🇱 Wroclaw, Poland

LKH; 🇦🇹 Klagenfurt, Austria

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ospedale Clinicizzato Universitario SS. Annunziata; 🇮🇹 Chieti, Italy

Barta and The London NHS Trust; 🇬🇧 London, United Kingdom

General Hospital AKH; 🇦🇹 Wien, Austria

Univercity Hospital Pilsen; 🇨🇿 Pizen, Czech Republic

Neurology Centre; 🇮🇳 Ahmedabad, India

Arcispedale Sant'Anna; 🇮🇹 Ferrara, Italy

Gartnavel General Hospital; 🇬🇧 Glasgow, United Kingdom

Fakultni nemocnice u svate' Anny v Brne; 🇨🇿 Brno, Czech Republic

University Hospital Olomouc; 🇨🇿 Olomouc, Czech Republic

Na Homolce Hospital; 🇨🇿 Prague, Czech Republic

Centrum Medyczne Osteomed; 🇵🇱 Bialobrzeska, Poland

Oddzial Neurologiczny; 🇵🇱 Zgierz, Poland

Kings College Hospital; 🇬🇧 London, United Kingdom

Solihull Hospital; 🇬🇧 West Midlands, United Kingdom