Clinical trial NCT01359826: The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients
Official title: The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Widespread Pain
Fibromyalgia
Keywords: Systemic Lupus Erythematosus
Widespread Pain
Fibromyalgia
Fatigue
Pain
Quality of Life
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Fatigue
timeFrame: Baseline and Week 14
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline and Week 6
measure: Pain
timeFrame: Baseline, week 6 and week 14
measure: Health related quality of life
timeFrame: Baseline, week 6 and week 14
measure: Overall health status
timeFrame: Baseline, week 6 and week 14
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: Emmanuel P. Katsaros, D.O.
role: PRINCIPAL_INVESTIGATOR
References: