Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been withdrawn prior to enrollment.
(PI has let the institution. We are unable to locate any study documents that would indicate study enrollment)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01359826
First received: April 19, 2011
Last updated: September 17, 2015
Last verified: September 2015
  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:


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.


Enrollment: 0
Study Start Date: October 2011
Study Completion Date: November 2013
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Forest Laboratories
Investigators
Principal Investigator: Emmanuel P. Katsaros, D.O. Loma Linda University
  More Information

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01359826     History of Changes
Other Study ID Numbers: 5110068 
Study First Received: April 19, 2011
Last Updated: September 17, 2015
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
Lupus Erythematosus, Systemic
Fibromyalgia
Myofascial Pain Syndromes
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on December 02, 2016