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Sponsors and Collaborators: |
Vanderbilt University UCB |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00156689 |
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.
Condition | Intervention | Phase |
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Chronic Idiopathic Axonal Polyneuropathy |
Drug: levetiracetam |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 30 |
Study Start Date: | August 2005 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject is or has:
Exclusion Criteria:
Subject is or has:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Gary W. Duncan, M.D. | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Gary Duncan, M.D. ) |
Study ID Numbers: | 050465 |
Study First Received: | September 7, 2005 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00156689 History of Changes |
Health Authority: | United States: Institutional Review Board |
polyneuropathy |
Nootropic Agents Neuromuscular Diseases Peripheral Nervous System Diseases |
Polyneuropathies Etiracetam Anticonvulsants |
Nootropic Agents Neuromuscular Diseases Therapeutic Uses Peripheral Nervous System Diseases Nervous System Diseases |
Polyneuropathies Etiracetam Central Nervous System Agents Pharmacologic Actions Anticonvulsants |