NCT00736151

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for phase_2

Geographic Reach
6 countries

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

2.9 years

First QC Date

August 13, 2008

Last Update Submit

August 6, 2009

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Change of pain intensity

    Baseline to week 8 or last visit

Secondary Outcomes (1)

  • The incidence of adverse events

    From baseline to week 8 or last visit

Study Arms (2)

1

EXPERIMENTAL

Ralfinamide administered orally at rising doses of 80 - 320 mg/day

Drug: Ralfinamide

2

ACTIVE COMPARATOR

Placebo controlled with randomization of 2:1

Drug: Ralfinamide

Interventions

RalfinamideDRUG

Oral tablets administered at rising doses of 80 - 320 mg/day

12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Universitatsklinik Fur Neurologie

Graz, Austria

Location

Universitatsklinik Fur Neurologie

Innsbruck, Austria

Location

LKH

Klagenfurt, Austria

Location

General Hospital AKH

Vienna, Austria

Location

Fakultni nemocnice u svate' Anny v Brne

Brno, Czechia

Location

Fakultni nemocnice Brno

Brno-Bhunice, Czechia

Location

University Hospital Olomouc

Olomouc, Czechia

Location

Univercity Hospital Pilsen

Pizen, Czechia

Location

Fakultni Thomayerova nemocnices poliklinikou

Prague, Czechia

Location

Na Homolce Hospital

Prague, Czechia

Location

Neurology Centre

Ahmedabad, India

Location

M.S. Ramaiah Medical

Bangalore, India

Location

R.S. R'S Trinity Acute Care Hospital

Chennai, India

Location

Sri Ramachandra medical College

Chennai, India

Location

Care Hospital

Hyderabad, India

Location

Chowpatty Medical Centre

Mumbai, India

Location

Brain and Mind Institute

Nagpur, India

Location

Apollo Hospital

Pradesh, India

Location

Brain Waves Clinic

Pune, India

Location

Vijaya Health Centre

Vadapalani, India

Location

Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

Ce. S.I. Fondazione Universitaria

Chieti, Italy

Location

Ospedale Clinicizzato Universitario SS. Annunziata

Chieti, Italy

Location

Arcispedale Sant'Anna

Ferrara, Italy

Location

Azienda Ospedaliera San Martino

Genova, Italy

Location

Universita degli Studi di Genova

Genova, Italy

Location

Ospedale Luigi Sacco

Grassi, Italy

Location

Ospedale Civile Umberto I

Mestre, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Istituto Scientifico di Riabilazione di Montescano

Montescano, Italy

Location

Policlinico Universitario Federico II

Napoli, Italy

Location

UCADH

Pavia, Italy

Location

Presidio Ospedaliero Monteluce

Perugia, Italy

Location

Universita degli Studi di Roma

Roma, Italy

Location

Policlinico G.B. Rossi

Verona, Italy

Location

Centrum Medyczne Osteomed

Bialobrzeska, Poland

Location

Centrum Kliniczno Badawcze

Elblag, Poland

Location

Wojewodzki Szpiyal Spejalistyczny

Gdansk, Poland

Location

Center Of Clinical Neurology

Krakow, Poland

Location

Osrodek Baden Klinicznych

Lublin, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Poland

Location

Wroclaw Medical University

Wroclaw, Poland

Location

Oddzial Neurologiczny

Zgierz, Poland

Location

Gartnavel General Hospital

Glasgow, United Kingdom

Location

Barta and The London NHS Trust

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Solihull Hospital

West Midlands, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Ralfinamide

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

May 1, 2004

Primary Completion

April 1, 2007

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

CZ(6)IT(15)PL(8)AU(4)GB(4)IN(10)