Sep 14, 2009
MS Trial Alert: Investigators Recruiting for Study of Duloxetine Hydrochloride to Treat Neuropathic Pain in MS
Summary: Investigators in the United States (US) are currently recruiting approximately 200 people with all types of MS who are experiencing central neuropathic pain for a clinical research study to determine if the investigational use of the oral study drug, duloxetine hydrochloride, versus placebo, is safe and effective at reducing neuropathic pain associated with MS. The study is sponsored by Eli Lilly and Company.
Rationale: Approximately 55% of people with MS experience pain. There are two types of chronic pain caused by MS – neuropathic pain (caused by nerve damage) and non-neuropathic pain (caused by muscle spasms or contractions). Neuropathic pain is often described as burning, stabbing, and shooting pain in the legs and arms; and numbness, tingling, prickly, or “pins and needles” sensations. The purpose of this study is to evaluate the investigational use of duloxetine hydrochloride to determine if it reduces neuropathic pain experienced by those with MS. The drug being studied belongs to the group of medications known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). The study drug has not been approved for the treatment of MS or MS pain.
Eligibility and Details: Participants should be 18 years and older, with a diagnosis of MS for at least 1 year, no MS flare-ups or change in disease treatment for the past three months, and having central neuropathic pain due to MS daily for a minimum of three months prior to study entry.
Participants will be randomly assigned to receive duloxetine hydrochloride or placebo for six weeks. If they complete this phase they will be invited to participate in an open-label phase during which participants will receive one of several doses of duloxetine hydrochloride. This is a 20-week study, in which participants will be expected to complete a maximum of six office visits and six telephone calls at specified time intervals. There will be approximately two weeks between each visit and/or call.
The primary outcome of this study is to determine the safety and effectiveness of the study drug versus placebo at reducing neuropathic pain in patients with MS. Secondary outcome measures include other pain assessments, along with assessments of quality of life and depression.
Contact: To learn more about enrollment criteria for this study, and to find out if you may be eligible to participate, please call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559). Sites are located in the following cities in the US:
1. Birmingham, Alabama
2. Phoenix, Arizona
3. Tucson, Arizona
4. Denver, Colorado
5. Boulder, Colorado
6. Aurora, Colorado
7. Bradenton, Florida
8. Lenexa, Kansas
9. Roseville, Michigan
10. Amherst, New York
11. Charlotte, North Carolina
12. Akron, Ohio
13. Allentown, Pennsylvania
14. Cordova, Tennessee