FibromyalgiaPhase 4NCT01014585

Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

A Phase 4 study testing Milnacipran in people with Fibromyalgia, run by Forest Laboratories at 58 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 is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the… Read more about this study

Who is it for?: Any age
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: 340 participants
Where: 58 sitesUnited States
Study dates: Nov 2009to May 2010
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Currently participating in Study MLN-MD-06
Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Who cannot join

Significant risk of suicide
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 12 months
Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
Active liver disease
Severe renal impairment
Platelet and bleeding disorders
Female patients who are pregnant or breastfeeding

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

United States58 sites

Forest Investigative Site 040
Albuquerque, New Mexico, 87108
Forest Investigative Site 028
Anderson, South Carolina, 29621
Forest Investigative Site 066
Atlanta, Georgia, 30319
Forest Investigative Site 009
Atlanta, Georgia, 30328
Forest Investigative Site 062
Birmingham, Alabama, 35205
Forest Investigative Site 065
Birmingham, Alabama, 35209
Forest Investigative Site 054
Charlotte, North Carolina, 28209
Forest Investigative Site 033
Cherry Hill, New Jersey, 08002
Forest Investigative Site 015
Chesapeake, Virginia, 23320
Forest Investigative Site 003
Cincinnati, Ohio, 45219
Forest Investigative Site 005
Cleveland, Ohio, 44122
Forest Investigative Site 059
Columbus, Ohio, 43212
Forest Investigative Site 050
Cromwell, Connecticut, 06416
Forest Investigative Site 049
Danbury, Connecticut, 06810
Forest Investigative Site 011
Delray Beach, Florida, 33484
Forest Investigative Site 051
Duncansville, Pennsylvania, 16635
Forest Investigative Site 044
Eugene, Oregon, 97401
Forest Investigative Site 010
Eugene, Oregon, 97404
Forest Investigative Site 031
Evansville, Indiana, 47713
Forest Investigative Site 064
Frederick, Maryland, 21702
Forest Investigative Site 007
Fresno, California, 93710
Forest Investigative Site 035
Great Neck, New York, 11021
Forest Investigative Site 018
Greensboro, North Carolina, 27408
Forest Investigative Site 002
Greenville, North Carolina, 27834
Forest Investigative Site 021
Greer, South Carolina, 29651
Forest Investigative Site 026
Honolulu, Hawaii, 96814
Forest Investigative Site 020
Jackson, Mississippi, 39202
Forest Investigative Site 061
Kalamazoo, Michigan, 49009
Forest Investigative Site 056
Libertyville, Illinois, 60048
Forest Investigative Site 046
Mechanicsburg, Pennsylvania, 17055
Forest Investigative Site 001
Medford, Oregon, 97504
Forest Investigative Site 052
Medford, Oregon, 97504
Forest Investigative Site 030
Newton, Massachusetts, 02462
Forest Investigative Site 048
North Dartmouth, Massachusetts, 02747
Forest Investigative Site 013
Ocala, Florida, 34471
Forest Investigative Site 016
Orlando, Florida, 32806
Forest Investigative Site 043
Palm Harbor, Florida, 34684
Forest Investigative Site 060
Pembroke Pines, Florida, 33029
Forest Investigative Site 038
Peoria, Illinois, 61614
Forest Investigative Site 032
Pismo Beach, California, 93449
Forest Investigative Site 041
Portland, Oregon, 97205
Forest Investigative Site 063
Racine, Wisconsin, 53406
Forest Investigative Site 014
Rochester, New York, 14618
Forest Investigative Site 025
Sacramento, California, 95825
Forest Investigative Site 024
Salisbury, North Carolina, 28144
Forest Investigative Site 006
Salt Lake City, Utah, 84102
Forest Investigative Site 019
San Diego, California, 92108
Forest Investigative Site 057
Santa Ana, California, 92705
Forest Investigative Site 047
Seattle, Washington, 98104
Forest Investigative Site 017
Springfield, Massachusetts, 01103
Forest Investigative Site 004
St Louis, Missouri, 63141
Forest Investigative Site 055
Stamford, Connecticut, 06905
Forest Investigative Site 027
Syracuse, New York, 13210
Forest Investigative Site 012
Tucson, Arizona, 85704
Forest Investigative Site 039
Vista, California, 92083
Forest Investigative Site 036
Wenatchee, Washington, 98801
Forest Investigative Site 042
Winston-Salem, North Carolina, 27103
Forest Investigative Site 008
Worcester, Massachusetts, 01610

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment

Conditions: Fibromyalgia
Being tested: Placebo, Milnacipran
Keywords: Milnacipran, Pain, Durability of Effect, Loss of Therapeutic Response, Fatigue, Forest Research Institute, Savella ®
Medical subject headings: Fibromyalgia, Pain, Fatigue

What participants receive

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

PlaceboDrug
Placebo tablets administered orally twice daily
MilnacipranDrug
Also called Savella ®
Milnacipran tablets administered orally twice daily

Study groups in NCT01014585
Study group	Role	What they receive
1	Placebo comparator	Placebo tablets administered orally twice daily Receives: Drug: Placebo
2	Experimental	Milnacipran tablets administered orally twice daily Receives: Drug: Milnacipran

What is being measured

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

Time to Loss of Therapeutic Response (LTR)
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment
Measured: From baseline Visit 3 (week 5) to Visit 7 (week 17)

Secondary outcomes (2)

Time to Worsening in Patient Global Impression of Change (PGIC)
Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. 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: From baseline Visit 3 (week 5) to Visit 7 (week 17)
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).
Measured: From baseline Visit 3 (week 5) to Visit 7 (week 17)

Timeline

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

Nov 2009May 2010

First posted17 Nov 2009 (estimated)
Study startNov 2009
Primary completionMay 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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01014585
Sponsor's protocol ID: MLN-MD-27
Status last verified: Sep 2011
First submitted: 13 Nov 2009
Last updated: 7 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.
PubMed 23953493

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 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
ClinicalTrials.gov ID: NCT01014585
Acronym / sponsor ID: MLN-MD-27
Conditions: Fibromyalgia
Keywords: Milnacipran, Pain, Durability of Effect, Loss of Therapeutic Response, Fatigue, Forest Research Institute, Savella ®
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Cypress Bioscience, Inc.
Study start: Nov 2009
Primary completion: May 2010 (actual)
First posted: 17 Nov 2009 (estimated)
Results: Posted 7 Sep 2011

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Placebo comparator	Drug: PlaceboPlacebo tablets administered orally twice daily
2	Experimental	Drug: MilnacipranMilnacipran tablets administered orally twice daily

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Currently participating in Study MLN-MD-06
Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Key exclusion criteria (8 listed)

Significant risk of suicide
History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
Myocardial infarction and/or stroke within the prior 12 months
Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
Active liver 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
PlaceboPlacebo tablets administered orally twice daily	Drug	1
MilnacipranAlso: Savella ®Milnacipran tablets administered orally twice daily	Drug	2

Primary outcome

Time to Loss of Therapeutic Response (LTR)
Time frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment

2 secondary outcomes

Time to Worsening in Patient Global Impression of Change (PGIC)
Time frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
Time frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)

Results and safety

Results posted to the registry on 7 Sep 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
Responders: Placebo (Milnacipran Withdrawn)	51	31
Responders: Milnacipran (Milnacipran Continued)	100	75
Non-Responders: Placebo (Milnacipran Withdrawn)	60	37
Non-Responders: Milnacipran (Milnacipran Continued)	129	99

Primary outcome: Time to Loss of Therapeutic Response (LTR)

Time frame: From baseline Visit 3 (week 5) to Visit 7 (week 17). Median (95% Confidence Interval). Unit: Days

Measure	Responders: Placebo (Milnacipran Withdrawn) n = 50	Responders: Milnacipran (Milnacipran Continued) n = 100	Non-Responders: Placebo (Milnacipran Withdrawn) n = 0	Non-Responders: Milnacipran (Milnacipran Continued) n = 0
Value	56 (28 to 85)	NA (NA to NA)	–	–

Responders: Placebo (Milnacipran Withdrawn) vs Responders: Milnacipran (Milnacipran Continued): Hazard Ratio (HR): 0.44 (95% CI 0.27 to 0.71), p = 0.0004, Log Rank
Responders: Placebo (Milnacipran Withdrawn): Days until LTR at the 25th percentile: 18
Responders: Milnacipran (Milnacipran Continued): Days until LTR at the 25th percentile: 45

Population analysed: The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.

2 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
Responders: Placebo (Milnacipran Withdrawn)	0 of 50 (0%)	8 of 50 (16%)	Not reported
Responders: Milnacipran (Milnacipran Continued)	1 of 100 (1%)	6 of 100 (6%)	Not reported
Non-Responders: Placebo (Milnacipran Withdrawn)	1 of 60 (1.7%)	10 of 60 (16.7%)	Not reported
Non-Responders: Milnacipran (Milnacipran Continued)	3 of 128 (2.3%)	30 of 128 (23.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23953493Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.

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.

Joel Trugman, MD study director

Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

58 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 58 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 2 inclusion and 8 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 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 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 7 Sep 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?

Time to Loss of Therapeutic Response (LTR) (time frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)). 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 NCT01014585, 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 7 Sep 2011.