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

August 13, 2008
August 6, 2009
May 2004
April 2007   (final data collection date for primary outcome measure)
Change of pain intensity [ Time Frame: Baseline to week 8 or last visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00736151 on ClinicalTrials.gov Archive Site
The incidence of adverse events [ Time Frame: From baseline to week 8 or last visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase II Dose Titration Study in Patients With Neuropathic Pain
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Neuropathic Pain
Drug: Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
  • Experimental: 1
    Ralfinamide administered orally at rising doses of 80 - 320 mg/day
    Intervention: Drug: Ralfinamide
  • Active Comparator: 2
    Placebo controlled with randomization of 2:1
    Intervention: Drug: Ralfinamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
Not Provided
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   India,   Italy,   Poland,   United Kingdom
 
NCT00736151
NW-1029/001/II/2003, EUDRACT Number 2004-000557-35
Not Provided
Stefano Rossetti, MD, Newron Pharmaceuticals S.p.A
Newron Sweden AB
Not Provided
Not Provided
Newron Sweden AB
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP