Phase II Dose Titration Study in Patients With Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Newron Sweden AB
ClinicalTrials.gov Identifier:
NCT00736151
First received: August 13, 2008
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Neuropathic Pain
Drug: Ralfinamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
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

Further study details as provided by Newron Sweden AB:

Primary Outcome Measures:
  • Change of pain intensity [ Time Frame: Baseline to week 8 or last visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: From baseline to week 8 or last visit ] [ Designated as safety issue: No ]

Enrollment: 272
Study Start Date: May 2004
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736151

  Hide Study Locations
Locations
Austria
Universitatsklinik Fur Neurologie
Graz, Austria
Universitatsklinik Fur Neurologie
Innsbruck, Austria
LKH
Klagenfurt, Austria
General Hospital AKH
Wien, Austria
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, Czech Republic
India
Neurology Centre
Ahmedabad, India
M.S. Ramaiah Medical
Bangalore, India
Sri Ramachandra medical College
Chennai, India
R.S. R'S Trinity Acute Care Hospital
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
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, Italy
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, Poland
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, United Kingdom
Sponsors and Collaborators
Newron Sweden AB
  More Information

No publications provided

Responsible Party: Stefano Rossetti, MD, Newron Pharmaceuticals S.p.A
ClinicalTrials.gov Identifier: NCT00736151     History of Changes
Other Study ID Numbers: NW-1029/001/II/2003, EUDRACT Number 2004-000557-35
Study First Received: August 13, 2008
Last Updated: August 6, 2009
Health Authority: Austria: Ethikkommission
Czech Republic: Ethics Committee
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014