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Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.
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.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 239 |
| Start date | 2008-10 |
| Completion | 2010-11 |
Conditions
- Multiple Sclerosis
Interventions
- Duloxetine Hydrochloride (HCI)
- Placebo
Primary outcomes
- Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) — Baseline, 6 weeks
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.
Countries
United States, Belgium, Canada, Poland