FibromyalgiaPhase 3NCT00098124

Study of Milnacipran for the Treatment of Fibromyalgia

A Phase 3 study testing milnacipran hydrochloride in people with Fibromyalgia, run by Forest Laboratories at 80 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

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. 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 hydrochloride
How many people: 1,200 participants
Where: 80 sitesUnited States
Study dates: Nov 2004to Dec 2006
Phase: Phase 3
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 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

Who cannot join

Psychiatric illness
Depression
Suicidal risk
Substance abuse
Pulmonary dysfunction
Renal impairment

Show all 12Show fewer

Active cardiac disease
Liver disease
Autoimmune disease
Cancer
Sleep apnea
Inflammatory bowel disease

Trial locations and contacts

80 sites in 1 country.

City, postcode or hospital

80 sites in 1 country

United States80 sites

Forest Investigative Site
Austin, Texas, 78705
Forest Investigative Site
Baltimore, Maryland, 21237
Forest Investigative Site
Bellingham, Washington, 98226
Forest Investigative Site
Bend, Oregon, 97701
Forest Investigative Site
Beverly Hills, California, 90211
Forest Investigative Site
Birmingham, Alabama, 35205
Forest Investigative Site
Bismarck, North Dakota, 58501
Forest Investigative Site
Bristol, Tennessee, 37620
Forest Investigative Site
Charlotte, North Carolina, 28209
Forest Investigative Site
Chattanooga, Tennessee, 37404
Forest Investigative Site
Cherry Hill, New Jersey, 08002
Forest Investigative Site
Chicago, Illinois, 60612
Forest Investigative Site
Clearwater, Florida, 33761
Forest Investigative Site
Clementon, New Jersey, 08021
Forest Investigative Site
Colorado Springs, Colorado, 80909
Forest Investigative Site
Colorado Springs, Colorado, 80910
Forest Investigative Site
Columbia, Maryland, 21045
Forest Investigative Site
Danbury, Connecticut, 06810
Forest Investigative Site
Decatur, Georgia, 30033
Forest Investigative Site
DeLand, Florida, 32720
Forest Investigative Site
Delray Beach, Florida, 33484
Forest Investigative Site
Duncanville, Pennsylvania, 16635
Forest Investigative Site
East Syracuse, New York, 13057
Forest Investigative Site
Eugene, Oregon, 97404
Forest Investigative Site
Evansville, Indiana, 47713
Forest Investigative Site
Everett, Washington, 98201
Forest Investigative Site
Fayetteville, North Carolina, 28304
Forest Investigative Site
Flowood, Mississippi, 39232
Forest Investigative Site
Frederick, Maryland, 21702
Forest Investigative Site
Great Neck, New York, 11021
Forest Investigative Site
Hickory, North Carolina, 28601
Forest Investigative Site
Honolulu, Hawaii, 96814
Forest Investigative Site
Jacksonville, Florida, 33216
Forest Investigative Site
Kalamazoo, Michigan, 49009
Forest Investigative Site
Lafayette, Indiana, 47904
Forest Investigative Site
Lexington, Kentucky, 40509
Forest Investigative Site
Libertyville, Illinois, 60048
Forest Investigative Site
Marion, Ohio, 43302
Forest Investigative Site
Medford, Oregon, 97504
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
Meridian, Idaho, 83642
Forest Investigative Site
Missoula, Montana, 59802
Forest Investigative Site
Mobile, Alabama, 36608
Forest Investigative Site
Montgomery, Alabama, 36111
Forest Investigative Site
Newton, Massachusetts, 02462
Forest Investigative Site
North Dartmouth, Massachusetts, 02747
Forest Investigative Site
Ocala, Florida, 34471
Forest Investigative Site
Oklahoma City, Oklahoma, 73112
Forest Investigative Site
Orangeburg, South Carolina, 29118
Forest Investigative Site
Ormond Beach, Florida, 32174
Forest Investigative Site
Palm Harbor, Florida, 34684
Forest Investigative Site
Pembroke Pines, Florida, 33029
Forest Investigative Site
Peoria, Arizona, 85381
Forest Investigative Site
Peoria, Illinois, 61614
Forest Investigative Site
Port Orange, Florida, 32127
Forest Investigative Site
Portland, Oregon, 97205
Forest Investigative Site
Racine, Wisconsin, 53406
Forest Investigative Site
Raleigh, North Carolina, 27609
Forest Investigative Site
Raleigh, North Carolina, 27612
Forest Investigative Site
Richmond, Virginia, 23294
Forest Investigative Site
Rochester, New York, 14618
Forest Investigative Site
Sacramento, California, 95825
Forest Investigative Site
San Antonio, Texas, 78205
Forest Investigative Site
San Diego, California, 92108
Forest Investigative Site
San Diego, California, 92117
Forest Investigative Site
Santa Ana, California, 92705
Forest Investigative Site
Santa Fe, New Mexico, 87505
Forest Investigative Site
Seattle, Washington, 98166
Forest Investigative Site
Spring Valley, California, 91978
Forest Investigative Site
St Louis, Missouri, 63141
Forest Investigative Site
Stamford, Connecticut, 06905
Forest Investigative Site
Sugarland, Texas, 77479
Forest Investigative Site
Tamarac, Florida, 33321
Forest Investigative Site
Torrance, California, 90505
Forest Investigative Site
Trumball, Connecticut, 06611
Forest Investigative Site
Virginia Beach, Virginia, 23454
Forest Investigative Site
Warwick, Rhode Island, 02886
Forest Investigative Site
Wenatchee, Washington, 98801
Forest Investigative Site
Wichita, Kansas, 67207
Forest Investigative Site
Winston-Salem, North Carolina, 27103

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About this study

Official title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

Conditions: Fibromyalgia
Being tested: milnacipran hydrochloride
Keywords: NSRI, milnacipran, fibromyalgia
Medical subject headings: Fibromyalgia

What participants receive

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

milnacipran hydrochlorideDrug

What is being measured

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

Composite responder analysis based on pain and patient global status, with or without physical function.

Secondary outcomes (3)

Quality of Life
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments

Timeline

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

Nov 2004Dec 2006

First posted6 Dec 2004 (estimated)
Study startNov 2004
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Enrolment: 1,200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00098124
Sponsor's protocol ID: MLN-MD-02
Status last verified: Dec 2007
First submitted: 3 Dec 2004
Last updated: 24 Dec 2007
Results posted: No

Publications

Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009.
PubMed 19108787

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
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

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
ClinicalTrials.gov ID: NCT00098124
Acronym / sponsor ID: MLN-MD-02
Conditions: Fibromyalgia
Keywords: NSRI, milnacipran, fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 participants
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Nov 2004
Study completion: Dec 2006
First posted: 6 Dec 2004 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

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

Key inclusion criteria (1 listed)

Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Key exclusion criteria (12 listed)

Psychiatric illness
Depression
Suicidal risk
Substance abuse
Pulmonary dysfunction

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
milnacipran hydrochloride	Drug	–

Primary outcome

Composite responder analysis based on pain and patient global status, with or without physical function.

3 secondary outcomes

Quality of Life
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
Derived from this study: PubMed 19108787Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009.

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.

The record lists no contact. Use the official record to reach the sponsor.

80 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 milnacipran hydrochloride in people with Fibromyalgia, run by Forest Laboratories at 80 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 1 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 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite responder analysis based on pain and patient global status, with or without physical function.. 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 NCT00098124, which also lists 1 linked publication.

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 24 Dec 2007.