FibromyalgiaPhase 3NCT00314249

Study of Milnacipran for the Treatment of Fibromyalgia

A Phase 3 study testing Milnacipran 100mg in people with Fibromyalgia, run by Forest Laboratories at 24 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate 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?: Milnacipran 100mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,025 participants
Where: 24 sitesUnited States
Study dates: Apr 2006to Jun 2008
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

Who cannot join

psychiatric illness,
depression,
suicidal risk,
substance abuse,
pulmonary dysfunction,
renal impairment,

Show all 11Show fewer

active cardiac disease,
liver disease,
autoimmune disease,
cancer,
inflammatory bowel disease

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Forest Investigative Site
Anderson, South Carolina, 29621
Forest Investigative Site
Atlanta, Georgia, 30328
Forest Investigative Site
Cleveland, Ohio, 44122
Forest Investigative Site
Columbus, Ohio, 43212
Forest Investigative Site
Eugene, Oregon, 97401
Forest Investigative Site
Fresno, California, 93710
Forest Investigative Site
Greensboro, North Carolina, 27408
Forest Investigative Site
Greer, South Carolina, 29651
Forest Investigative Site
Haddon Heights, New Jersey, 08035
Forest Investigative Site
Johnson City, New York, 13790
Forest Investigative Site
Mechanicsburg, Pennsylvania, 17055
Forest Investigative Site
Omaha, Nebraska, 68134
Forest Investigative Site
Pismo Beach, California, 93449
Forest Investigative Site
Richardson, Texas, 75080
Forest Investigative Site
Springfield, Massachusetts, 01107
Forest Investigative Site
St. Petersburg, Florida, 33702
Forest Investigative Site
St. Petersburg, Florida, 33709
Forest Investigative Site
Stuart, Florida, 34996
Forest Investigative Site
Syracuse, New York, 13210
Forest Investigative Site
Toledo, Ohio, 43623
Forest Investigative Site
Tuscaloosa, Alabama, 35406
Forest Investigative Site
Virginia Beach, Virginia, 23454
Forest Investigative Site
Vista, California, 92083
Forest Investigative Site
Worcester, Massachusetts, 01610

Other trials in United States

About this study

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

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Conditions: Fibromyalgia
Being tested: Placebo, Milnacipran 100mg
Keywords: Fibromyalgia
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, oral administration, twice daily for 12 weeks
Milnacipran 100mgDrug
Milnacipran 100mg per day (50mg BID [twice a day])

Study groups in NCT00314249
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo, oral administration, twice daily for 12 weeks Receives: Drug: Placebo
Milnacipran	Experimental	Milnacipran 100mg/day (50mg BID [twice a day]) Receives: Drug: Milnacipran 100mg

What is being measured

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

Composite Syndrome Responder Status
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Measured: At the end of the three-month stable dose treatment phase
Composite Pain Responder Status
Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."
Measured: At the end of three-month stable dose treatment phase

Secondary outcomes (4)

Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase
Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.
PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).
Measured: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.
Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.
PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.
Measured: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.
Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.
MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."
Measured: Baseline through end of week 12 (Visit TX12)
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12
Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains \& 2 component summaries (mental and physical); assessing quality of life, health \& functional status.
SF-36 PCS: weighted summary of physical function using all 8 domains.
Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.
SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.
Measured: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase

Timeline

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

Apr 2006Jun 2008

First posted13 Apr 2006 (estimated)
Study startApr 2006
Primary completionJun 2008

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.
Publications (2)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
Who is masked: Participant, Investigator
Enrolment: 1,025 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00314249
Sponsor's protocol ID: MLN-MD-03
Status last verified: Jan 2010
First submitted: 11 Apr 2006
Last updated: 20 Jan 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
PubMed 22429066
Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.
PubMed 20496365

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 20 Jan 2010. 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 Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
ClinicalTrials.gov ID: NCT00314249
Acronym / sponsor ID: MLN-MD-03
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,025 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Cypress Bioscience, Inc.
Study start: Apr 2006
Primary completion: Jun 2008 (actual)
First posted: 13 Apr 2006 (estimated)
Results: Posted 2 Nov 2009

Clinical summary

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

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo, oral administration, twice daily for 12 weeks
Milnacipran	Experimental	Drug: Milnacipran 100mgMilnacipran 100mg/day (50mg BID [twice a day])

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 (11 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
PlaceboPlacebo, oral administration, twice daily for 12 weeks	Drug	Placebo
Milnacipran 100mgMilnacipran 100mg per day (50mg BID [twice a day])	Drug	Milnacipran

Primary outcome

Composite Syndrome Responder Status
Time frame: At the end of the three-month stable dose treatment phase
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Composite Pain Responder Status
Time frame: At the end of three-month stable dose treatment phase
Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."

4 secondary outcomes

Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase
Time frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.
Time frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.
Time frame: Baseline through end of week 12 (Visit TX12)
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12
Time frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase

Results and safety

Results posted to the registry on 2 Nov 2009, 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	509	357
Milnacipran	516	353

Primary outcome: Composite Syndrome Responder Status

Time frame: At the end of the three-month stable dose treatment phase. Number. Unit: Syndrome Responder Participants

Measure	Placebo n = 509	Milnacipran n = 516
Value	56	103

Placebo vs Milnacipran: Odds Ratio (OR): 2.06 (95% CI 1.45 to 2.94), p <0.001, Regression, Logistic

Population analysed: The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).

Primary outcome: Composite Pain Responder Status

Time frame: At the end of three-month stable dose treatment phase. Number. Unit: Pain Responder Participants

Measure	Placebo n = 509	Milnacipran n = 516
Value	90	147

Placebo vs Milnacipran: Odds Ratio (OR): 1.86 (95% CI 1.38 to 2.51), p <0.001, Regression, Logistic

Population analysed: The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 509 (1.4%)	382 of 509 (75%)	Not reported
Milnacipran	10 of 516 (1.9%)	434 of 516 (84.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22429066Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
Derived from this study: PubMed 20496365Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.

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.

24 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 100mg in people with Fibromyalgia, run by Forest Laboratories at 24 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 11 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 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 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 2 Nov 2009). 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?

Composite Syndrome Responder Status (time frame: At the end of the three-month stable dose treatment phase). The study lists 2 primary outcomes in all. 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 NCT00314249, which also lists 2 linked publications.

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 20 Jan 2010.