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

NCT01359826 | Withdrawn Phase 4

• 1 other identifier: 5110068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Widespread Pain; Fibromyalgia

Keywords

Systemic Lupus Erythematosus; Widespread Pain; Fibromyalgia; Fatigue; Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Fatigue

  Baseline and Week 6

• Pain

  Baseline, week 6 and week 14

• Health related quality of life

  Baseline, week 6 and week 14

• Overall health status

  Baseline, week 6 and week 14

Study Arms (2)

Milnacipran

EXPERIMENTAL

Patients administered milnacipran will receive a dose escalation to 50 mg twice a day over 12 days and continued at this dose until week 6. If tolerated and a 15% improvement in fatigue from baseline is achieved by assessment on the FSS, then patients will continue taking 50 mg twice a day until the end of the study on day 98 (week 14). Otherwise, the dose of milnacipran will be titrated upward to 100 mg twice a day over 12 days and continued at this dose until day 98 (week 14).

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

Placebo tablets administered orally twice a day for 14 weeks.

Drug: Milnacipran

Interventions

Milnacipran DRUG

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.

Also known as: Savella

Milnacipran; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fibromyalgia; Fatigue; Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Emmanuel P. Katsaros, D.O.

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: May 25, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)