The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients
Status:
Withdrawn
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the
physical, social, psychological health and quality of life of patients. Fatigue and pain are
aspects of SLE patients which affect their health related quality of life (HRQOL). The
purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients
with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to
determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male
and female patients, 18 years and older, will be recruited for a 15-week study, in which
patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo.
Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo
groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran
has been shown to be an effective treatment for pain, fatigue and physical function in FMS
patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue
in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS
studies, that the milnacipran treated patients will have less fatigue than those in the
placebo group. In addition, compared to control arm, those treated with the study drug will
have less pain and improved quality of life.