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

NCT00156689 | Completed Phase 2

• 1 other identifier: 050465
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Idiopathic Axonal Polyneuropathy

Keywords

polyneuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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.

Interventions

levetiracetam DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vanderbilt University: lead
• UCB Pharma: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Polyneuropathies

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gary W. Duncan, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2005
• Study Completion: May 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

US (1)