Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011804
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-02-28
Brief Title:
Topiramate in the Treatment of Sciatica
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Topiramate in the Treatment of Sciatica
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 625 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 individuals care
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 625 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 individuals care
Detailed Description:
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 legs 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 AMPAkainate 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-D-0105 | None | None | None |