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

Fibromyalgia Clinical Trial

Official title:

The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01359826
• Other study ID #: 5110068
• Status: Withdrawn
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: September 17, 2015
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Lupus Erythematosus, Systemic
• Myofascial Pain Syndromes
• Systemic Lupus Erythematosus
• Widespread Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	A change in fatigue from baseline will be assessed with values obtained at week 14 using the Fatigue Severity Scale (FSS) in both the treatment and control groups.	Baseline and Week 14	No
Secondary	Fatigue	A change in fatigue will be assessed with values obtained at baseline and week 6 using the FSS and Visual Analogue Score (VAS) Fatigue.	Baseline and Week 6	No
Secondary	Pain	A change in pain will be assessed with values obtained at baseline, week 6, and 14 using the VAS Pain, and the Short Form - McGill Pain Questionnaire (SF-MPQ).	Baseline, week 6 and week 14	No
Secondary	Health related quality of life	Health related quality of life will be assessed with values obtained at baseline, week 6, and 14 using the Short form-36 (SF-36).	Baseline, week 6 and week 14	No
Secondary	Overall health status	A change in overall health status will be assessed using the Patient Global Impression of Change (PGIC) at baseline, week 6, and 14.	Baseline, week 6 and week 14	No