Phase II Dose Titration Study in Patients With Neuropathic Pain

August 6, 2009 updated by: Newron Pharmaceuticals SPA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Ralfinamide administered orally at rising doses of 80 - 320 mg/day
Drug: Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
ACTIVE_COMPARATOR: 2
Placebo controlled with randomization of 2:1
Drug: Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of pain intensity
Time Frame: Baseline to week 8 or last visit
Baseline to week 8 or last visit

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse events
Time Frame: From baseline to week 8 or last visit
From baseline to week 8 or last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newron Pharmaceuticals SPA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW-1029/001/II/2003
  • EUDRACT Number 2004-000557-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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