Systemic Lupus ErythematosusPhase 4NCT01359826
The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients
A Phase 4 study testing Milnacipran in people with Systemic Lupus Erythematosus and Widespread Pain, run by Loma Linda University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Widespread Pain, Fibromyalgia
- What is being tested?
- Milnacipran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erythematosus, Widespread Pain, Fibromyalgia
- Being tested
- Milnacipran
- Keywords
- Systemic Lupus Erythematosus, Widespread Pain, Fibromyalgia, Fatigue, Pain, Quality of Life
- Medical subject headings
- Lupus Erythematosus, Systemic, Fibromyalgia, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Also called Savella
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Milnacipran |
| Placebo | Placebo comparator | Placebo tablets administered orally twice a day for 14 weeks. Receives: Drug: Milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 14
Secondary outcomes (4)
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.
Measured: Baseline and Week 6
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).
Measured: Baseline, week 6 and week 14
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).
Measured: Baseline, week 6 and week 14
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.
Measured: Baseline, week 6 and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionNov 2013
Why it stopped: PI has let the institution. We are unable to locate any study documents that would indicate study enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Emmanuel P. Katsaros, D.O., Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359826
- Sponsor's protocol ID
- 5110068
- Status last verified
- Sep 2015
- First submitted
- 19 Apr 2011
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort
- ClinicalTrials.gov ID
- NCT01359826
- Acronym / sponsor ID
- 5110068
- Conditions
- Systemic Lupus Erythematosus, Widespread Pain, Fibromyalgia
- Keywords
- Systemic Lupus Erythematosus, Widespread Pain, Fibromyalgia, Fatigue, Pain, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has let the institution. We are unable to locate any study documents that would indicate study enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Experimental | Drug: MilnacipranPatients 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). |
| Placebo | Placebo comparator | Drug: MilnacipranPlacebo tablets administered orally twice a day for 14 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilnacipranAlso: SavellaAfter 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. | Drug | Milnacipran, Placebo |
Primary outcome
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.
4 secondary outcomes
Fatigue
Time frame: Baseline and Week 6
Pain
Time frame: Baseline, week 6 and week 14
Health related quality of life
Time frame: Baseline, week 6 and week 14
Overall health status
Time frame: Baseline, week 6 and week 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel P. Katsaros, D.O. principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Milnacipran in people with Systemic Lupus Erythematosus and Widespread Pain, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline and Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.