Status:
COMPLETED
Duloxetine for Multiple Sclerosis Pain
Lead Sponsor:
Eli Lilly and Company
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropat...
Detailed Description
Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fa...
Eligibility Criteria
Inclusion
- Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria
- Adult males or females
- Have a score of 4 or greater on the daily 24-hour average pain score
- Females must test negative for pregnancy at study entry
- Complete the daily diaries for at least 70% of the days of the study
- Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:
- Diagnosis of MS at least 1 year prior to study entry
- No MS flares or change in disease treatment for the 3 months prior to study entry
- Daily pain due to MS for a minimum of 3 months prior to study entry
Exclusion
- Are currently in a clinical trial of MS disease-modifying therapy
- Have pain that cannot be clearly differentiated from causes other than MS
- Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
- History of substance abuse or dependence
- Are pregnant or breast-feeding
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00755807
Start Date
October 1 2008
End Date
November 1 2010
Last Update
December 9 2011
Active Locations (22)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35294
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85018
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tucson, Arizona, United States, 85741
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, United States, 80045