Clinical Trial: Topiramate in the Treatment of Sciatica
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Topiramate in the Treatment of Sciatica
Brief Summary:
This study will test the effectiveness of topiramate to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although sciatica is common, there are no good treatments for it. Topiramate belongs to a group of medications commonly used to treat pain caused by nerve damage.
Patients between 18 and 75 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study. (This is taken from the first paragraph of the Qualification Criteria in the consent form. The inclusion criteria on page 6 of the protocol say "low back pain of 3 months duration or longer present at least 5 out of 7 days a week" and signs and symptoms of lumbar radiculopathy. Which is correct?)
Participants will provide a medical history, as well as occupational and social information. They will undergo a standard neurological examination, including a test of cognitive (thinking) abilities, muscular function, reflexes and a sensory examination. The latter involves testing with a pin placed on the surface of the skin. Participants will also have routine blood tests and will fill out questionnaires on their daily functioning and psychological well being. Additional procedures may include magnetic resonance imaging (MRI) scans and possible referral to a psychiatrist for evaluation of depression or emotional difficulties.
This "cross-over" study consists of two parts. In one part, patients will receive topiramate and in the other, an active placebo. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug. Diphenhydramine (Benadryl) is the active placebo used
Detailed Summary:
Irritation or damage to lumbar nerve roots referred to as lumbar radiculopathy or sciatica is a very common clinical entity with a lifetime prevalence of 1-3% in the adult population. Lumbar radiculopathy typically causes back pain and sharp, shooting pain in the leg(s). Despite its prevalence and disabling characteristics, sciatica has never been selectively studied in drug trials. We propose to study the anti-epileptic drug topiramate, which combines multiple potential analgesic actions including sodium channel blockade, GABA agonist-like effects and AMPA/kainate glutamate receptor blockade. Patients will include men and women of all ethnic backgrounds between the ages of 18 and 75 who have had signs and symptoms of sciatica for 3 months or more.
The design is a double-blind, two period cross-over study comparing topiramate to placebo. Patients will be called twice a week to individually titrate doses of topiramate towards a maximum of 800 mg per day and monitor side effects. The primary outcome measures in this study will be the daily pain scores in the low back, in the leg and combined. Patients' quality of life and activities of daily living will be secondary outcome measures as assessed by the SF 36, Oswestry, and Beck questionnaires. Sixty five patients will be enrolled in this study and the duration of the study will be 17 weeks, including one week baseline, four week escalation, two week maintenance and two week wash out for topiramate and placebo respectively.
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
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Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: February 28, 2001
Date Started: February 2001
Date Completion: February 2005
Last Updated: March 3, 2008
Last Verified: February 2005
