FibromyalgiaPhase 4NCT01077375

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

A Phase 4 study testing Milnacipran in people with Fibromyalgia, run by Forest Laboratories at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: 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: 107 participants
Where: 26 sitesUnited States
Study dates: Feb 2010to Jan 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of fibromyalgia
Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
Duloxetine must have been prescribed for the treatment of Fibromyalgia
Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Who cannot join

Suicidal risk
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 6 months
Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
Substance abuse
Pulmonary dysfunction

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Severe renal impairment
Active cardiac disease
Liver disease
Uncontrolled narrow-angle glaucoma
Autoimmune disease
Cancer
Inflammatory bowel disease
Unstable endocrine disease
Prostatic enlargement
Female patients who are pregnant or breastfeeding

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Forest Investigative Site 006
Atlanta, Georgia, 30328
Forest Investigative Site 024
Atlanta, Georgia, 30328
Forest Investigative Site 017
Bellevue, Washington, 98007
Forest Investigative Site 023
Charlotte, North Carolina, 28209
Forest Investigative Site 002
Cincinnati, Ohio, 45219
Forest Investigative Site 003
Cleveland, Ohio, 44122
Forest Investigative Site 022
Cromwell, Connecticut, 06416
Forest Investigative Site 021
Danbury, Connecticut, 06810
Forest Investigative Site 007
Delray Beach, Florida, 33484
Forest Investigative Site 015
Evansville, Indiana, 47713
Forest Investigative Site 011
Greer, South Carolina, 29651
Forest Investigative Site 010
Jackson, Mississippi, 39202
Forest Investigative Site 020
Mechanicsburg, Pennsylvania, 17055
Forest Investigative Site 001
Medford, Oregon, 97504
Forest Investigative Site 008
Ocala, Florida, 34471
Forest Investigative Site 009
Orlando, Florida, 32806
Forest Investigative Site 016
Orlando, Florida, 32806
Forest Investigative Site 026
Racine, Wisconsin, 53406
Forest Investigative Site 013
Sacramento, California, 95825
Forest Investigative Site 004
Salt Lake City, Utah, 84102
Forest Investigative Site 025
St Louis, Missouri, 63141
Forest Investigative Site 012
St. Petersburg, Florida, 33709
Forest Investigative Site 014
Syracuse, New York, 13210
Forest Investigative Site 019
Tampa, Florida, 33614
Forest Investigative Site 018
Willingboro, New Jersey, 08046
Forest Investigative Site 005
Worchester, Massachusetts, 01610

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Read the detailed description

Two weeks Duloxetine 60 mg Open-Label Period
Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
One week Double-Blind Down-Taper Period

Conditions: Fibromyalgia
Being tested: Placebo, Milnacipran
Keywords: Milnacipran, Duloxetine, Switch, Forest Research Institute
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
- Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
- Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
MilnacipranDrug
Also called Savella
- Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
- Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.

Study groups in NCT01077375
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo tablets, twice a day, oral administration Receives: Drug: Placebo
Milnacipran	Experimental	Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses. Receives: Drug: Milnacipran

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.
Measured: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.

Secondary outcomes (1)

Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
Measured: Change from Baseline (Week 3) to Visit 5 (Week 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Jan 2011

First posted1 Mar 2010 (estimated)
Study startFeb 2010
Primary completionDec 2010
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
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: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077375
Sponsor's protocol ID: MLN-MD-28
Status last verified: Dec 2011
First submitted: 25 Feb 2010
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
ClinicalTrials.gov ID: NCT01077375
Acronym / sponsor ID: MLN-MD-28
Conditions: Fibromyalgia
Keywords: Milnacipran, Duloxetine, Switch, Forest Research Institute
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Cypress Bioscience, Inc.
Study start: Feb 2010
Primary completion: Dec 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 1 Mar 2010 (estimated)
Results: Posted 26 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Detailed description

Two weeks Duloxetine 60 mg Open-Label Period
Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
One week Double-Blind Down-Taper Period

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
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets, twice a day, oral administration
Milnacipran	Experimental	Drug: MilnacipranMilnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of fibromyalgia
Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
Duloxetine must have been prescribed for the treatment of Fibromyalgia
Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

Key exclusion criteria (16 listed)

Suicidal risk
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 6 months
Systolic blood pressure > 160 mm Hg or mean diastolic blood pressure > 100 mm Hg at Screening (Visit 1)
Substance abuse

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
Placebo* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. * Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.	Drug	Placebo
MilnacipranAlso: Savella* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper. * Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.	Drug	Milnacipran

Primary outcome

Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
Time frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.

1 secondary outcome

Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score
Time frame: Change from Baseline (Week 3) to Visit 5 (Week 13)

Results and safety

Results posted to the registry on 26 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	21	11
Milnacipran	86	51

Primary outcome: Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)

Time frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.. Number. Unit: participants

Measure	Placebo n = 21	Milnacipran n = 79
Value	5	26

Population analysed: ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a nearly 10 month period from March 4th, 2010 through December 22, 2010.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	16 of 21 (76.2%)	Not reported
Milnacipran	2 of 85 (2.4%)	63 of 85 (74.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Allan Spera study director

Forest Research Institute Inc., A Subsidiary of Forest Laboratories

26 sites 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 Fibromyalgia, run by Forest Laboratories at 26 sites 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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?

Yes. Results are posted in the registry (first posted 26 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) (time frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077375.

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 26 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.