Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254657
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2005-11-15
Brief Title:
Levetiracetam for Treatment of Pain Associated With Fibromyalgia
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2013-05
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:
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo Levetiracetam an anti-seizure drug is currently FDA-approved and marketed for use in patients with seizures Levetiracetam may relieve pain by reducing abnormal activity in the nervous system A placebo is an inactive substance
Detailed Description:
The UCSF Pain Clinical Research Center PCRC will be conducting this investigator-initiated 9-week randomized double-blind placebo-controlled parallel group study of Levetiracetam There will be a total of 6 study visits Visit 1 is a screening visit to assess subject eligibility followed by a one-week period of baseline daily pain and sleep assessments Visit 2 one week after Visit 1 subjects will be randomized in a 32-randomization scheme and administered study medication Subjects randomized to the treatment group will start Levetiracetam at 1 tablet of 500mgday and will titrate by 500mg each week to a maximum dose of 3000 mgday Visits 3 4 5 and 6 occurring 2 4 6 and 8 weeks after started study drug include safety and efficacy assessments Study drug taper is initiated at Visit 6
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