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.
Between 350,000 and 400,000 Americans have Multiple Sclerosis, a chronic neurological disease characterized by demyelination and axonal degeneration. Pain is an important symptom of MS, reported in 44% to 80% of patients. Duloxetine is FDA apprBetween 350,000 and 400,000 Americans have Multiple Sclerosis, a chronic neurological disease characterized by demyelination and axonal degeneration. Pain is an important symptom of MS, reported in 44% to 80% of patients. Duloxetine is FDA approved for use in treatment of diabetic painful neuropathy and depression. Since the analgesic mechanism of action of Duloxetine is believed to occur in the Central Nervous System, there is reason to believe that it may also be effective in central pain conditions, such as MS. Our study design includes a 1:1 randomization of Duloxetine to placebo. We hypothesize that the Duloxetine group will experience reductions in the weekly 24 hour average and worst pain scores that exceed 1.5 and that are significantly greater than reductions achieved in the placebo group. We also hypothesize that Duloxetine will be well tolerated with no significant group differences in adverse effects, sleep and quality of life as measured by the SF-36 approved for use in treatment of diabetic painful neuropathy and depression. Since the analgesic mechanism of action of Duloxetine is believed to occur in the Central Nervous System, there is reason to believe that it may also be effective in central pain conditions, such as MS. Our study design includes a 1:1 randomization of Duloxetine to placebo. We hypothesize that the Duloxetine group will experience reductions in the weekly 24 hour average and worst pain scores that exceed 1.5 and that are significantly greater than reductions achieved in the placebo group. We also hypothesize that Duloxetine will be well tolerated with no significant group differences in adverse effects, sleep and quality of life as measured by the SF-36.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
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
Evergreen Healthcare
Kirkland, Washington, United States
Percent Change in Worst Pain Score
Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.
Time frame: at week 6
Percent Change in Average Pain Score.
Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.
Time frame: at week 6
Global Impression of Change
global impression: "How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible
Time frame: Week 6 vs baseline
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