The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Systemic Lupus Erythematosus Widespread Pain Fibromyalgia	Drug: Milnacipran	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Fibromyalgia Lupus

Drug Information available for: Milnacipran Milnacipran hydrochloride

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

Fatigue [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Fatigue [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
A change in fatigue will be assessed with values obtained at baseline and week 6 using the FSS and Visual Analogue Score (VAS) Fatigue.
Pain [ Time Frame: Baseline, week 6 and week 14 ] [ Designated as safety issue: No ]
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).
Health related quality of life [ Time Frame: Baseline, week 6 and week 14 ] [ Designated as safety issue: No ]
Health related quality of life will be assessed with values obtained at baseline, week 6, and 14 using the Short form-36 (SF-36).
Overall health status [ Time Frame: Baseline, week 6 and week 14 ] [ Designated as safety issue: No ]
A change in overall health status will be assessed using the Patient Global Impression of Change (PGIC) at baseline, week 6, and 14.

Estimated Enrollment:	50
Study Start Date:	October 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Savella

Arms

Assigned Interventions

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 Name: 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 Name: Savella

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359826

Contacts

Contact: Marisela Santiago	909-558-4000 ext 46199	MSantiago@llu.edu
Contact: Emmanuel P Katsaros, D.O.	909-558-4909	EKatsaros@llu.edu

Locations

United States, California
Loma Linda University Medical Center	Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Mariesela Santiago 909-558-4000 ext 46199 MSantiago@llu.edu
Contact: Emmanuel P Katsaros, D.O. 909-558-4909
Principal Investigator: Emmanuel P Katsaros, D.O.
Sub-Investigator: Ioana Moldovan, M.D.
Loma Linda University Medical Center	Recruiting
Loma Linda, California, United States, 92354
Principal Investigator: Emmanuel P Katsaros, D.O.

Sponsors and Collaborators

Emmanuel Katsaros

Forest Laboratories

Investigators

Principal Investigator:

Emmanuel P. Katsaros, D.O.

Loma Linda University

More Information

No publications provided

Responsible Party:	Emmanuel Katsaros, Prinicpal Investigator, Loma Linda University
ClinicalTrials.gov Identifier:	NCT01359826 History of Changes
Other Study ID Numbers:	FOR-5110068
Study First Received:	April 19, 2011
Last Updated:	October 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:

Systemic Lupus Erythematosus
Widespread Pain
Fibromyalgia

Fatigue
Pain
Quality of Life

Additional relevant MeSH terms:

Fatigue
Fibromyalgia
Myofascial Pain Syndromes
Lupus Erythematosus, Systemic
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Milnacipran

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on May 19, 2013