A Study to Determine if Levetiracetam Will Assist Those Suffering From Chronic Idiopathic Axonal Polyneuropathy.
Considering the mechanisms of action which provide efficacy in epilepsy, it is hypothesized that treatment with levetiracetam will reduce the neuronal excitability involved in neuropathic pain associated with CIAP. Thus, there is a potential for levetiracetam to bring therapeutic benefit for the subjects because of its specific mechanism of action, its safety profile and the absence of interaction with other drugs.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Study in a Double Blind, Randomized, Placebo-Controlled, Parallel-Group, 16 Week, Trial Design Evaluating the Efficacy and Safety of Levetiracetam 500 mg Tablets in Bid Administration (Daily Dose Ranging From 1000 mg to 3000 mg), in Adults (>18 Years of Ages) Suffering From Chronic Idiopathic Axonal Polyneuropathy|
- Exploratory efficacy endpoint
- The primary exploratory efficacy variable is the absolute change in the average weekly PSS from the baseline period to the last 7 days of the evaluation period (Last Observation Carried Forward).
- The secondary exploratory efficacy endpoints and/or analysis methods are:
- Reduction of at least 30% in the mean PSS over the last week of the evaluation period compared to the baseline period (30% Responder).
- Reduction of at least 50% in the mean PSS over the last week of the evaluation period compared to the baseline period (50% Responder).
- Percent change in the mean PSS from the baseline week to each weekly mean.
- Absolute change from the baseline week to each weekly mean in the PSS.
- Changes from the baseline week to each weekly mean, and to the last week of evaluation period, in the SIS.
- Absolute changes from the randomization visit to each evaluation period/early discontinuation visit, in each score (Total pain score, Sensory score, Affective score, Present Pain Intensity (PPI) and VAS) of the SF-MPQ.
- Subject Global Impression of Change (SGIC) at visit 6 or the last visit of the evaluation period.
- Clinician's Global Impression of Change (CGIC) at visit 6 or the last visit of the evaluation period.
|Study Start Date:||August 2005|
|Study Completion Date:||May 2007|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Gary W. Duncan, M.D.||Vanderbilt University|