At a glance
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A Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Multiple Sclerosis. Completed, enrolled 38 participants across 1 site.
Detailed Summary
Many patients with Multiple Sclerosis experience pain that is caused by the effects of MS on the nervous system. The purpose of this study is to see if an investigational drug (Duloxetine) will reduce pain in subjects with MS. The US Food and Drug administration (FDA) has approved this drug for use with depression or pain from diabetes.However, it is considered investigational for this study because it has not been approved for patients with MS. This study will recruit patients with MS who have central pain which is 4 or greater on a scale of 1-10. Patients must have experienced pain for 2 months or longer prior to begining the study.The study will last 10 weeks, patients will be randomized either Duloxetine or placebo and will be carefully monitored throughout the study. Patients will keep pain/sleep diaries during the study period and will be provided Ibuprofen for pain control.
Study Details
Timeline
Interventions
Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.
Subjects are randomized to either Duloxetine or Placebo