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

September 17, 2015 updated by: Loma Linda University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Milnacipran
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
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.
Other Names:
  • Savella
Placebo Comparator: Placebo
Placebo tablets administered orally twice a day for 14 weeks.
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.
Other Names:
  • Savella

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline and Week 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline and Week 6
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
Pain
Time Frame: Baseline, week 6 and week 14
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
Health related quality of life
Time Frame: Baseline, week 6 and week 14
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
Overall health status
Time Frame: Baseline, week 6 and week 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Emmanuel P. Katsaros, D.O., Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5110068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on Milnacipran

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe