The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients

Last updated: September 17, 2015
Sponsor: Loma Linda University
Overall Status: Trial Not Available

Phase

4

Condition

Systemic Lupus Erythematosus

Pain (Pediatric)

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT01359826
5110068
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female or male age 18 or older.

  • Has fulfilled the 1997 classification criteria for SLE.

  • Has chronic WSP or FMS.

  • Score a 40 or more on the visual analog score (VAS) for fatigue.

Exclusion

Exclusion Criteria:

  • Has a chronic inflammatory autoimmune condition other than SLE.

  • Has an acute or uncontrolled co-morbid medical condition.

  • Uncontrolled narrow angle glaucoma.

  • Has been hospitalized in the last four months for a lupus flare.

  • Pregnant or breast feeding.

  • Has a current or prior major depressive disorder or other DSM IV diagnosis within 2years of the screening visit.

  • The use of antidepressants, MAO inhibitors, antipsychotics or lithium

  • The use of pregabalin or milnacipran within 2-4 weeks.

  • Has received cyclophosphamide and or rituximab within 4 and 6 months.

  • Unable to speak, read, and understand English.

Study Design

Study Start date:
October 01, 2011
Estimated Completion Date:
November 30, 2013

Connect with a study center

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.