Trial | NCT00736151  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    272
The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.
Study Started
May 31
2004
Primary Completion
Apr 30
2007
Last Update
Aug 07
2009
Estimate

Drug Ralfinamide

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

1 Experimental

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

2 Active Comparator

Placebo controlled with randomization of 2:1

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
No Results Posted