Protocol Number: 01-D-0105

Title:

Topiramate in the Treatment of Sciatica

Number:

01-D-0105

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 in this study. Diphenhydramine is an allergy medication with very mild side effects, such as drowsiness. During both parts of the study-topiramate and placebo-patients will keep a daily log in which they rate their pain, record other procedures they undergo, such as injections and manipulations, and record medication side effects.

In the first week of the study, patients will remain on their current medications and record pain levels once a day. After the first week, they will begin taking the study drugs-either topiramate in increasing doses ranging from 50 to 400 mg. or diphenhydramine in doses ranging from 6.25 to 50 mg. The drug doses will be increased gradually over 4 weeks to minimize possible side effects. Increases will continue until the maximum tolerated dose is reached. Patients will continue on the highest tolerated dose for two weeks and then be tapered off gradually over 12 days. They will remain off drugs completely for a 2-day washout period and then begin the next treatment. Those who took topiramate for the first part will take diphenhydramine for the second part and vice versa.

A study nurse will call patients twice a week throughout the study to check for problems and answer questions. A physician will see patients 6 weeks after the start of each treatment. During the last visit, at the end of the study, patients will repeat the questionnaires they filled out at the beginning of the study. Patients and their doctors will be informed of the medications that were effective in each individual's care.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Low Back Pain

Lumbar Radiculopathy

Anticonvulsants

Neuropathic Pain

Analgesia

Recruitment Keywords:

Sciatica

Low Back Pain

Analgesia

Conditions:

Sciatica

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

The treatment of neuropathic pain: antidepressants and opioids

Contribution of central neuroplasticity to pathological pain: review of clinical and experimental evidence

Topiramate relieves refractory intercostal neuralgia

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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