Download Efficacy and Safety of Ralfinamide in Patients With Chronic

Efficacy and Safety of Ralfinamide in Patients With Chronic
Neuropathic Low Back Pain
Status: Active, not recruiting
Study Phase: Phase 3
Start Date: January 2009 | Completion Date: June 2010
Condition(s): Pain
Full Title of Study
A Phase III Study to Assess the Efficacy and Safety of Ralfinamide.
Overview
The aim of the study is to determine if an experimental drug, ralfinamide, relieves
your neuropathic low back pain, and if it demonstrates superiority to placebo, a
"dummy" or sugar pill that contains no active medication. Ralfinamide, given as either
160 mg/day or 320 mg/day, taken in a divided dose twice-a-day, will be compared
with placebo. If you are randomly (by chance) selected to receive placebo, you will
receive this medication throughout the treatment period of the study. Data from this
study will provide essential information for choosing the doses of ralfinamide to be
used in the treatment of this type of pain and potentially other types of pain.
Detailed Description
Ralfinamide has been shown to be an effective analgesic in a number of animal
models of neuropathic pain. These observed effects of ralfinamide may have been
achieved by targeting both hyperactivity of peripheral sensory neurons, through
voltage-dependent, Na+-channel blockade [Stummann et al., 2005] and Ca++-channel
blockade, and sensitization of central neurons, through NMDA-receptor modulation.
Evidence of efficacy in mixed peripheral neuropathic pain syndromes has been
demonstrated in Study 001 [Anand et al., 2008]. In particular patients with
neuropathic pain due to nerve compression (e.g., compression radiculopathy, lumbar
spinal stenosis, sciatic nerve compression, spinal root compression, intercostal
neuralgia) showed response to ralfinamide treatment. In this sub-population,
statistically significant improvements in severity of pain, as measured on the VAS and
11-point Likert scales, as well as a greater proportion of patients meeting "responder"
criteria, compared to the placebo group, were noted with ralfinamide treatment.
Similarly, patients in the study classified as having neuropathic low back pain also
showed significant benefit from treatment with ralfinamide; therefore, the focus of
the current study is on this indication. The current study will evaluate the safety,
tolerability and analgesic efficacy of ralfinamide in patients with chronic neuropathic
low back pain due to nerve compression, i.e., compression radiculopathy or posttraumatic/post-surgical lumbar radiculopathy. It should also be noted that no current
drug therapy has global regulatory approval for treating this type of chronic
neuropathic low back pain; therefore, should ralfinamide prove effective in this
patient population, it would be satisfying an unmet medical need.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Newron
Collaborator: Parexel
Collaborator: CliniRx
Study Director: Stefano Rossetti, MD Newron
Trial Location Details
Facility: Parexel London, United Kingdom
Interventions
Drug: Ralfinamide
Ralfinamide Oral Tablets, 160 or 320 mg per day
Information Source
ID Number: NW-1029/01-08
NCT Identifier: NCT01019824
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01019824
ClinicalTrials.gov processed this data on October 12, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
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