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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00156689
First received: September 7, 2005
Last updated: January 2, 2008
Last verified: January 2008
  Purpose

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
Chronic Idiopathic Axonal Polyneuropathy
Drug: levetiracetam
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • 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.

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be eligible to participate in this study, the following criteria must be met:

Subject is or has:

  • Male or female outpatient greater than or equal to 18 years of age;
  • Suffering presently from neuropathic pain, which has been present for at least 3 months and is clinically felt to be associated with CIAP;
  • CIAP defined by the following clinical criteria: Primary = distal predominant sensory loss in feet and/or hands; preserved motor strength and deep tendon reflexes; normal routine nerve conduction study velocities and amplitudes; no identifiable etiology after appropriate evaluation; Secondary = neuropathic pain in feet; neuropathic pain in hands; abnormal QSART, age 45-70 years, autonomic dysfunction.
  • Neuropathic pain at entry into the study must meet the following criteria: a VAS of at least 40 mm at visit 2 (to assess pain intensity during the past week) and with an average daily score of at least 4 on the PSS during the baseline period as evaluated on a minimum of 4 days;
  • An estimated creatinine clearance of at least 80 ml/min. If the subject has a history or symptoms of renal impairment, an estimated creatinine clearance will be obtained at the baseline visit. If the estimated creatinine clearance is </= 80 ml/min the subject is not eligible to participate;
  • Capable of understanding and completing diaries and questions, and adhering to the protocol, in the judgment of the investigator;
  • Females of childbearing potential must have a negative serum pregnancy test at the selection visit and at Visits 2 - 6 (and a negative result on the accompanying urine pregnancy test at Visit 2). Females must be surgically sterile, postmenopausal for at least 2 years prior to visit 1, must have undergone tubal ligation or using an acceptable method of birth control for the duration of the study (oral contraceptives must be stable for at least one full month prior to visit 1). Abstinence is not an acceptable method of contraception for the study.
  • Written informed consent obtained prior to procedures being performed and the consent process documented;
  • Able to follow written and verbal instructions in English or in Spanish and be willing to attend the required study visits and complete the required daily assessments (Spanish speaking patients can only be enrolled at sites with staff who are fluent in Spanish);
  • A telephone where they can be directly contacted.

Exclusion Criteria:

  • Subjects must be excluded if they meet any of the following criteria.

Subject is or has:

  • Receiving professional psychological support (such as cognitive behavioral therapy) currently or within 2 weeks prior to visit 1 specifically for coping with PHN;
  • Previous neurolytic or neurosurgical therapy for peripheral neuropathy pain, at any time in the subject's history or treatment with TENS (transelectroneuro stimulation) currently or within the past 2 weeks;
  • Known co-existent source of pain or painful peripheral neuropathy, (untreated hypoparathyroidism, vitamin B12 deficiency, amyloidosis, connective tissue disease, porphyria, diabetic peripheral neuropathy, complex regional pain syndrome, alcoholism, hepatitis, uremia, syphilis, myeloma, malignancy (less than 5 years in remission), peripheral nerve trauma (including surgery), drug induced peripheral neuropathy (e.g., vinca alkaloids, taxols, etc.) or other systemic disease associated with a secondary painful neuropathy);
  • Known significant neurological disorder other than the study disease or a condition which can mimic stroke with distal neurological deficit (amyotrophy, radiculopathy, history of TIAs, multiple sclerosis, or any amputations);
  • Conditions known to be associated with immunosuppressive states;
  • Significant lactose intolerance;
  • Presence of signs or symptoms of rapidly progressing clinically significant brain disorder or dementia;
  • Significant and severe medical conditions (such as severe cardiac dysfunction, bone marrow suppression, severe hepatic disease) which may impair reliable participation in the trial;
  • Clinically significant deviations from reference range values for laboratory parameters such as hepatic markers (ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, γGT), platelets < 100,000/μl, leukocyte count < 3500/mm3 or neutrophil cells < 1,800/μl;
  • Alcohol or drug abuse currently or within the past year according to DSM-IV-TR criteria as interpreted by the investigator;
  • Current participation or participation within the last 30 days in another investigational clinical trial or dosing with any non-study drug not approved for use in the United States;
  • Clinically significant major depression defined as a Beck Depression Inventory Score > 21 at selection including those with a history of Bipolar Disorder;
  • History of suicidal ideation in the past 3 months or suicide attempt within the last 10 years;
  • Intake of more than two classes of medications to treat pain at study entry (see Sectio on Concomitant Treatment);
  • Intake of levetiracetam within 2 weeks prior to visit 1;
  • Currently receiving treatment with a spinal cord stimulator
  • Intake of benzodiazepines (for any indication), skeletal muscle relaxants, orally administered steroids, local and topical agents for the relief of peripheral polyneuropathy pain, and anticonvulsant agents within 2 weeks prior to visit 1 or during the study;
  • Discontinued treatment with antidepressants < 4 weeks prior to visit 1;
  • Current use or use within 2 weeks prior to visit 1 of topical steroids specifically for the treatment of peripheral neuropathy pain;
  • Current use or use within 2 weeks prior to visit 1 of lidocaine patches as a therapy for peripheral neuropathy pain, regardless of frequency or duration of use;
  • History of hormone replacement therapy which has not been stable and ongoing for at least 2 weeks prior to visit 1;
  • A female subject who is currently breast feeding an infant;
  • Presence of an indwelling cardiac pacemaker or other indwelling electrical device that would preclude performance of nerve conduction studies.
  • Known hypersensitivity to levetiracetam or any of the inactive ingredients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156689

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
UCB, Inc.
Investigators
Principal Investigator: Gary W. Duncan, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Gary Duncan, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00156689     History of Changes
Obsolete Identifiers: NCT00298948
Other Study ID Numbers: 050465
Study First Received: September 7, 2005
Last Updated: January 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
polyneuropathy

Additional relevant MeSH terms:
Polyneuropathies
Stress, Psychological
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Behavioral Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014