FibromyalgiaPhase 3NCT00797797

Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

A Phase 3 study testing No Treatment Added and Milnacipran Added in people with Fibromyalgia, run by Forest Laboratories at 60 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

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with 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?: No Treatment Added and Milnacipran Added
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 364 participants
Where: 60 sitesUnited States
Study dates: Nov 2008to Jan 2010
Phase: Phase 3
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 defined by 1990 American College of Rheumatology (ACR) Criteria
tolerate at least 300 mg/day of pregabalin
have an incomplete response to pregabalin treatment

Who cannot join

suicidal risk
substance abuse
pulmonary dysfunction
renal impairment
active cardiac disease
liver disease

Show all 12Show fewer

narrow angle glaucoma
autoimmune disease
cancer
inflammatory bowel disease
unstable endocrine disease
prostatic enlargement

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

United States60 sites

Forest Investigative Site
Albuquerque, New Mexico, 87108
Forest Investigative Site
Anaheim, California, 92801
Forest Investigative Site
Atlanta, Georgia, 30328
Forest Investigative Site
Baltimore, Maryland, 21208
Forest Investigative Site
Bellevue, Washington, 98004
Forest Investigative Site
Bellingham, Washington, 98226
Forest Investigative Site
Birmingham, Alabama, 35205
Forest Investigative Site
Cincinnati, Ohio, 45219
Forest Investigative Site
Clearwater, Florida, 33765
Forest Investigative Site
Cleveland, Ohio, 44122
Forest Investigative Site
Couer D'Alene, Idaho, 83814
Forest Investigative Site
Cromwell, Connecticut, 06416
Forest Investigative Site
Danbury, Connecticut, 06810
Forest Investigative Site
Daytona Beach, Florida, 32117
Forest Investigative Site
Delray Beach, Florida, 33484
Forest Investigative Site
Denver, Colorado, 80239
Forest Investigative Site
Eugene, Oregon, 97404
Forest Investigative Site
Evansville, Indiana, 47713
Forest Investigative Site
Fort Myers, Florida, 33912
Forest Investigative Site
Greer, South Carolina, 29651
Forest Investigative Site
Honolulu, Hawaii, 96814
Forest Investigative Site
Hot Springs, Arkansas, 71913
Forest Investigative Site
Houston, Texas, 77074
Forest Investigative Site
Houston, Texas, 77104
Forest Investigative Site
Indianapolis, Indiana, 46254
Forest Investigative Site
Indianapolis, Indiana, 46260
Forest Investigative Site
Jackson, Mississippi, 39202
Forest Investigative Site
Jacksonville, Florida, 32216
Forest Investigative Site
Lake Jackson, Texas, 77566
Forest Investigative Site
Medford, Oregon, 97504
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
Mesa, Arizona, 85210
Forest Investigative Site
Miami, Florida, 33169
Forest Investigative Site
No. Dartmouth, Massachusetts, 02747
Forest Investigative Site
Ocala, Florida, 34471
Forest Investigative Site
Omaha, Nebraska, 68134
Forest Investigative Site Orl2
Orlando, Florida, 32806
Forest Investigative Site
Orlando, Florida, 32806
Forest Investigative Site
Ormond Beach, Florida, 32174
Forest Investigative Site PP1
Pembroke Pines, Florida, 33024
Forest Investigative Site PP2
Pembroke Pines, Florida, 33029
Forest Investigative Site
Peoria, Arizona, 85381
Forest Investigative Site
Pismo Beach, Florida, 93449
Forest Investigative Site
Portland, Oregon, 97210
Forest Investigative Site
Racine, Wisconsin, 53406
Forest Investigative Site
Sacramento, California, 95821
Forest Investigative Site
Sacramento, California, 95825
Forest Investigative Site
Salt Lake City, Utah, 84102
Forest Investigative Site
Salt Lake City, Utah, 84106
Forest Investigative Site SEA1
Seattle, Washington, 98104
Forest Investigative Site SEA2
Seattle, Washington, 98104
Forest Investigative Site
Spokane, Washington, 99204
Forest Investigative Site
St Louis, Missouri, 63141
Forest Investigative Site
St. Petersburg, Florida, 33709
Forest Investigative Site
Syracuse, New York, 13210
Forest Investigative Site
Tampa, Florida, 33614
Forest Investigative Site
Torrance, California, 90505
Forest Investigative Site
Walnut Creek, California, 94598
Forest Investigative Site
Woodstock, Vermont, 05091
Forest Investigative Site
Worcester, Massachusetts, 01610

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About this study

Official title: A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Conditions: Fibromyalgia
Being tested: No Treatment Added, Milnacipran Added
Keywords: fibromyalgia, milnacipran, pregabalin, treatment, 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.

No Treatment AddedDrug
Also called Lyrica (r)
No added treatment
Milnacipran AddedDrug
Milnacipran 100 mg/d added

Study groups in NCT00797797
Study group	Role	What they receive
Milnacipran Added	Experimental	Not described Receives: Drug: Milnacipran Added
No Treatment Added	Experimental	Not described Receives: Drug: No Treatment Added

What is being measured

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

Patient Global Impression of Change (PGIC) Responder Rate at End of Study
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
Measured: End of Randomized treatment period (11 weeks)

Secondary outcomes (1)

Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).
Measured: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

Timeline

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

Nov 2008Jan 2010

First posted25 Nov 2008 (estimated)
Study startNov 2008
Primary completionNov 2009
Study completionJan 2010

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797797
Sponsor's protocol ID: MLN-MD-15
Status last verified: Jan 2011
First submitted: 24 Nov 2008
Last updated: 16 Feb 2011
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

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
ClinicalTrials.gov ID: NCT00797797
Acronym / sponsor ID: MLN-MD-15
Conditions: Fibromyalgia
Keywords: fibromyalgia, milnacipran, pregabalin, treatment, Forest Research Institute
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Nov 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 16 Feb 2011

Clinical summary

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

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Milnacipran Added	Experimental	Drug: Milnacipran Added
No Treatment Added	Experimental	Drug: No Treatment Added

Who may qualify

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

Key inclusion criteria (3 listed)

diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
tolerate at least 300 mg/day of pregabalin
have an incomplete response to pregabalin treatment

Key exclusion criteria (12 listed)

suicidal risk
substance abuse
pulmonary dysfunction
renal impairment
active cardiac disease

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
No Treatment AddedAlso: Lyrica (r)No added treatment	Drug	No Treatment Added
Milnacipran AddedMilnacipran 100 mg/d added	Drug	Milnacipran Added

Primary outcome

Patient Global Impression of Change (PGIC) Responder Rate at End of Study
Time frame: End of Randomized treatment period (11 weeks)
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.

1 secondary outcome

Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
Time frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

Results and safety

Results posted to the registry on 16 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Treatment Added	178	123
Milnacipran Added	184	141

Primary outcome: Patient Global Impression of Change (PGIC) Responder Rate at End of Study

Time frame: End of Randomized treatment period (11 weeks). Number. Unit: participants

Measure	No Treatment Added n = 173	Milnacipran Added n = 179
Responder	36	83
Non-Responder	137	96

No Treatment Added vs Milnacipran Added: p <0.001, Regression, Logistic

Population analysed: All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events, defined as adverse events which occurred or worsened after starting randomized study drug, were collected from December 2008 to November 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Treatment Added	6 of 178 (3.4%)	38 of 178 (21.3%)	Not reported
Milnacipran Added	5 of 184 (2.7%)	90 of 184 (48.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

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.

Patricia D'Astoli study director

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

60 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing No Treatment Added and Milnacipran Added in people with Fibromyalgia, run by Forest Laboratories at 60 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 3 inclusion and 12 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 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Feb 2011). 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?

Patient Global Impression of Change (PGIC) Responder Rate at End of Study (time frame: End of Randomized treatment period (11 weeks)). 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 NCT00797797.

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 16 Feb 2011.