A Study to Determine if Levetiracetam Will Assist Those Suffering From Chronic Idiopathic Axonal Polyneuropathy.
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|ClinicalTrials.gov Identifier: NCT00156689|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Idiopathic Axonal Polyneuropathy||Drug: levetiracetam||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||May 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156689
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Gary W. Duncan, M.D.||Vanderbilt University Medical Center|