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Phase II Dose Titration Study in Patients With Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ralfinamide
Sponsored by
Newron Pharmaceuticals SPA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuropathic Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitatsklinik Fur Neurologie
  • Universitatsklinik Fur Neurologie
  • LKH
  • General Hospital AKH
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u svate' Anny v Brne
  • University Hospital Olomouc
  • Univercity Hospital Pilsen
  • Na Homolce Hospital
  • Fakultni Thomayerova nemocnices poliklinikou
  • Neurology Centre
  • M.S. Ramaiah Medical
  • R.S. R'S Trinity Acute Care Hospital
  • Sri Ramachandra medical College
  • Care Hospital
  • Chowpatty Medical Centre
  • Brain and Mind Institute
  • Apollo Hospital
  • Brain Waves Clinic
  • Vijaya Health Centre
  • Ospedali Riuniti di Bergamo
  • Ce. S.I. Fondazione Universitaria
  • Ospedale Clinicizzato Universitario SS. Annunziata
  • Arcispedale Sant'Anna
  • Azienda Ospedaliera San Martino
  • Universita degli Studi di Genova
  • Ospedale Luigi Sacco
  • Ospedale Civile Umberto I
  • Ospedale San Raffaele
  • Istituto Scientifico di Riabilazione di Montescano
  • Policlinico Universitario Federico II
  • UCADH
  • Presidio Ospedaliero Monteluce
  • Universita degli Studi di Roma
  • Policlinico G.B. Rossi
  • Centrum Medyczne Osteomed
  • Centrum Kliniczno Badawcze
  • Wojewodzki Szpiyal Spejalistyczny
  • Center Of Clinical Neurology
  • Osrodek Baden Klinicznych
  • Wojskowy Instytut Medyczny
  • Wroclaw Medical University
  • Oddzial Neurologiczny
  • Gartnavel General Hospital
  • Barta and The London NHS Trust
  • Kings College Hospital
  • Solihull Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Placebo controlled with randomization of 2:1

Outcomes

Primary Outcome Measures

Change of pain intensity

Secondary Outcome Measures

The incidence of adverse events

Full Information

First Posted
August 13, 2008
Last Updated
August 6, 2009
Sponsor
Newron Pharmaceuticals SPA
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1. Study Identification

Unique Protocol Identification Number
NCT00736151
Brief Title
Phase II Dose Titration Study in Patients With Neuropathic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Newron Pharmaceuticals SPA

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ralfinamide administered orally at rising doses of 80 - 320 mg/day
Arm Title
2
Arm Type
Active Comparator
Arm Description
Placebo controlled with randomization of 2:1
Intervention Type
Drug
Intervention Name(s)
Ralfinamide
Intervention Description
Oral tablets administered at rising doses of 80 - 320 mg/day
Primary Outcome Measure Information:
Title
Change of pain intensity
Time Frame
Baseline to week 8 or last visit
Secondary Outcome Measure Information:
Title
The incidence of adverse events
Time Frame
From baseline to week 8 or last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universitatsklinik Fur Neurologie
City
Graz
Country
Austria
Facility Name
Universitatsklinik Fur Neurologie
City
Innsbruck
Country
Austria
Facility Name
LKH
City
Klagenfurt
Country
Austria
Facility Name
General Hospital AKH
City
Wien
Country
Austria
Facility Name
Fakultni nemocnice Brno
City
Brno-Bhunice
Country
Czech Republic
Facility Name
Fakultni nemocnice u svate' Anny v Brne
City
Brno
Country
Czech Republic
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Univercity Hospital Pilsen
City
Pizen
Country
Czech Republic
Facility Name
Na Homolce Hospital
City
Prague
Country
Czech Republic
Facility Name
Fakultni Thomayerova nemocnices poliklinikou
City
Praha
Country
Czech Republic
Facility Name
Neurology Centre
City
Ahmedabad
Country
India
Facility Name
M.S. Ramaiah Medical
City
Bangalore
Country
India
Facility Name
R.S. R'S Trinity Acute Care Hospital
City
Chennai
Country
India
Facility Name
Sri Ramachandra medical College
City
Chennai
Country
India
Facility Name
Care Hospital
City
Hyderabad
Country
India
Facility Name
Chowpatty Medical Centre
City
Mumbai
Country
India
Facility Name
Brain and Mind Institute
City
Nagpur
Country
India
Facility Name
Apollo Hospital
City
Pradesh
Country
India
Facility Name
Brain Waves Clinic
City
Pune
Country
India
Facility Name
Vijaya Health Centre
City
Vadapalani
Country
India
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
Ce. S.I. Fondazione Universitaria
City
Chieti
Country
Italy
Facility Name
Ospedale Clinicizzato Universitario SS. Annunziata
City
Chieti
Country
Italy
Facility Name
Arcispedale Sant'Anna
City
Ferrara
Country
Italy
Facility Name
Azienda Ospedaliera San Martino
City
Genova
Country
Italy
Facility Name
Universita degli Studi di Genova
City
Genova
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Grassi
Country
Italy
Facility Name
Ospedale Civile Umberto I
City
Mestre
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Istituto Scientifico di Riabilazione di Montescano
City
Montescano
Country
Italy
Facility Name
Policlinico Universitario Federico II
City
Napoli
Country
Italy
Facility Name
UCADH
City
Pavia
Country
Italy
Facility Name
Presidio Ospedaliero Monteluce
City
Perugia
Country
Italy
Facility Name
Universita degli Studi di Roma
City
Roma
Country
Italy
Facility Name
Policlinico G.B. Rossi
City
Verona
Country
Italy
Facility Name
Centrum Medyczne Osteomed
City
Bialobrzeska
Country
Poland
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
Country
Poland
Facility Name
Wojewodzki Szpiyal Spejalistyczny
City
Gdansk
Country
Poland
Facility Name
Center Of Clinical Neurology
City
Krakow
Country
Poland
Facility Name
Osrodek Baden Klinicznych
City
Lublin
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
Country
Poland
Facility Name
Wroclaw Medical University
City
Wroclaw
Country
Poland
Facility Name
Oddzial Neurologiczny
City
Zgierz
Country
Poland
Facility Name
Gartnavel General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Barta and The London NHS Trust
City
London
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
Facility Name
Solihull Hospital
City
West Midlands
Country
United Kingdom

12. IPD Sharing Statement

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Phase II Dose Titration Study in Patients With Neuropathic Pain

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