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

NCT01359826 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-09-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

Milnacipran

After dose escalations, patients will receive Milnacipran administered at 50 mg twice a day after for 12 weeks or milnacipran 50 mg twice day for 4 weeks and then 100 mg twice a day for an additional 6 weeks depending on tolerability and fatigue response.

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Emmanuel P. Katsaros, D.O. · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359826 on ClinicalTrials.gov