Duloxetine for Multiple Sclerosis Pain

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 neuropathic pain due to Multiple Sclerosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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