Clinical Trial: A Study to Determine if Levetiracetam Will Assist Those Suffering From Chronic Idiopathic Axonal Polyneuropathy.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 D

Brief Summary: 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.

Detailed Summary:

Based on literature and expert opinion, and despite the efforts made to better treat the spectrum of neuropathic pains, there are still unmet needs. The available treatments are not effective as monotherapy administration in the vast majority of patients and polypharmacy with several medications is often necessary. Tricyclic antidepressants (TCAs), mainly amitriptyline, are still a mainstay of treatment for painful peripheral neuropathy, but at the risk of some dose-limiting adverse events, which may reduce their effectiveness. TCA treatment effect is inconsistent and limited by side effects. In one clinical trial while about 50% of patients achieved significant or complete relief of pain 81% experienced side effects and in 71% the side effects were dose limiting. TCAs can produce sedation, urinary retention, and orthostatic hypotension that are of particular concern in the elderly and patients with cardiovascular disease. In the same study desipramine was associated with a slightly lower rate of side effects it offered only 40% of patients significant or complete relief of neuropathic pain. Fluoxetine was no more effective than placebo in pain relief. (Max, 1992). Due to the scarcity of controlled clinical trials and the inconclusive results of available trials, physicians vary markedly in their suggested regimens for neuropathic pain management. (Beydoun, 1999).

Antiepileptic drugs are being used more frequently in non-epileptic indications such as neuropathic pain. One of the mechanisms by which neuropathic pain occurs is related to an increased excitability of central neurons. Although their precise mechanism of action in neuropathic pain remains unknown, antiepileptic drugs are believed to exert their antineuralgic activity by suppressing the neuronal hyperexcitability state that characterizes neuropathic pain. A small crossover trial of carbamazepine produced clinic
Sponsor: Vanderbilt University

Current Primary Outcome:

  • 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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.


Information By: Vanderbilt University

Dates:
Date Received: September 7, 2005
Date Started: August 2005
Date Completion:
Last Updated: January 2, 2008
Last Verified: January 2008