View Clinical Trial (Medical Research Study)
The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort
| City: |
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Loma Linda |
| State: |
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California |
| Zip Code: |
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92354 |
| Conditions: |
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Systemic Lupus Erythematosus - Widespread Pain - Fibromyalgia |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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 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 2
years 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.
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| NCT ID: |
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NCT01359826 |
| Primary Contact: |
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Principal Investigator
Emmanuel P. Katsaros, D.O.
Loma Linda University
Marisela Santiago
Phone: 909-558-4000 ext. 46199
Email: MSantiago@llu.edu
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| Backup Contact: |
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Email: EKatsaros@llu.edu
Emmanuel P Katsaros, D.O.
Phone: 909-558-4909
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| Location Contact: |
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Loma Linda, California 92354
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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