Primary FibromyalgiaPhase 2MyFiNCT01328002

Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

A Phase 2 study testing Milnacipran in people with Primary Fibromyalgia, run by Forest Laboratories at 47 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia. Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Primary 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: 116 participants
Where: 47 sitesUnited States
Study dates: 30 Apr 2011to 31 Aug 2012
Phase: Phase 2
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 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of primary fibromyalgia
13-17 years of age
To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Who cannot join

Severe psychiatric illness
Severe renal impairment
Evidence of active liver disease
Pregnant or breastfeeding
Significant risk of suicidality
Unable, unwilling or inadvisable to discontinue prohibited medications

Show all 10Show fewer

History of alcohol abuse or drug abuse or dependence, within previous year
Current systemic infection
Autoimmune disease
History of seizure disorder (other than febrile seizures)

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

Forest Investigative Site 038
Akron, Ohio, 44308
Forest Investigative Site 018
Albuquerque, New Mexico, 87109
Forest Investigative Site 009
Ann Arbor, Michigan, 48104
Forest Investigative Site 023
Austin, Texas, 78732
Forest Investigative Site 006
Bellevue, Washington, 98007
Forest Investigative Site 040
Birmingham, Alabama, 35205
Forest Investigative Site 068
Birmingham, Alabama, 35216
Forest Investigative Site 058
Blue Ridge, Georgia, 30513
Forest Investigative Site 033
Bullhead City, Arizona, 86442
Forest Investigative Site 022
Chicago, Illinois, 60634
Forest Investigative Site 016
Cincinnati, Ohio, 45219
Forest Investigative Site 025
Clinton, Utah, 84015
Forest Investigative Site 034
Colorado Springs, Colorado, 80907
Forest Investigative Site 047
Cromwell, Connecticut, 06416
Forest Investigative Site 015
Dayton, Ohio, 45432
Forest Investigative Site 012
Fresno, California, 93710
Forest Investigative Site 045
Fresno, California, 93720
Forest Investigative Site 051
Fresno, California, 93721
Forest Investigative Site 061
Gainesville, Florida, 32607
Forest Investigative Site 046
Greer, South Carolina, 29650
Forest Investigative Site 005
Indianapolis, Indiana, 46250
Forest Investigative Site 017
Louisville, Kentucky, 40202
Forest Investigative Site 021
Lynchburg, Virginia, 24503
Forest Investigative Site 066
Mechanicsburg, Pennsylvania, 17055
Forest Investigative Site 019
Middleburg Heights, Ohio, 44130
Forest Investigative Site 001
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 027
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 035
Orange, California, 92868
Forest Investigative Site 053
Orange, California, 92868
Forest Investigative Site 041
Orange City, Florida, 32763
Forest Investigative Site 059
Orlando, Florida, 32806
Forest Investigative Site 010
Peoria, Illinois, 61614
Forest Investigative Site 054
Philadelphia, Pennsylvania, 19139
Forest Investigative Site 004
Racine, Wisconsin, 53406
Forest Investigative Site 062
Raleigh, North Carolina, 27612
Forest Investigative Site 024
Rochester Hills, Michigan, 48307
Forest Investigative Site 050
Sacramento, California, 95825
Forest Investigative Site 013
Salt Lake City, Utah, 84102
Forest Investigative Site 003
San Antonio, Texas, 78215
Forest Investigative Site 042
San Antonio, Texas, 78258
Forest Investigative Site 031
Savannah, Georgia, 31406
Forest Investigative Site 063
Seattle, Washington, 98104
Forest Investigative Site 014
Spring Hill, Florida, 34609
Forest Investigative Site 036
Stevensville, Michigan, 49127
Forest Investigative Site 055
West Palm Beach, Florida, 33409
Forest Investigative Site 049
Whitehouse Station, New Jersey, 08889
Forest Investigative Site 052
Winston-Salem, North Carolina, 27103

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About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Read the detailed description

8 weeks open-label treatment period with milnacipran.
Followed by randomization to 8-weeks double blind treatment period for eligible patients

Conditions: Primary Fibromyalgia
Being tested: Milnacipran, Placebo
Keywords: Fibromyalgia, Pediatric Fibromyalgia, Adolescent Fibromyalgia, milnacipran, Savella, loss of therapeutic response, Forest Research Institute, Pain, Fatigue, Serotonin Norepinephrine Reuptake Inhibitors, Randomized Withdrawal
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.

MilnacipranDrug
Also called Savella
Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.
Oral administration, twice daily dosing
PlaceboDrug
matching placebo tablets daily

Study groups in NCT01328002
Study group	Role	What they receive
Milnacipran	Experimental	oral administration, twice daily dosing Receives: Drug: Milnacipran
Placebo	Placebo comparator	oral administration, twice daily dosing Receives: Drug: Placebo

What is being measured

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

Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
Measured: Change from Visit 7 (Week 8) to Visit 10 (Week 16)

Secondary outcomes (1)

Patient Global Impression of Severity (PGIS)
The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill
Measured: Change from Visit 7 (Week 8) to Visit 10 (Week 16)

Timeline

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

30 Apr 201131 Aug 2012

First posted4 Apr 2011 (estimated)
Study start30 Apr 2011
Primary completion31 Aug 2012
Study completion31 Aug 2012

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 Primary 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01328002
Sponsor's protocol ID: MLN-MD-14
Acronym: MyFi
Status last verified: Mar 2019
First submitted: 31 Mar 2011
Last updated: 14 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9.
PubMed 26112278

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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All Primary Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
ClinicalTrials.gov ID: NCT01328002
Acronym / sponsor ID: MyFi / MLN-MD-14
Conditions: Primary Fibromyalgia
Keywords: Fibromyalgia, Pediatric Fibromyalgia, Adolescent Fibromyalgia, milnacipran, Savella, loss of therapeutic response, Forest Research Institute, Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 116 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Cypress Bioscience, Inc.
Study start: 30 Apr 2011 (actual)
Primary completion: 31 Aug 2012 (actual)
Study completion: 31 Aug 2012 (actual)
First posted: 4 Apr 2011 (estimated)
Results: Posted 14 May 2019

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 is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Detailed description

8 weeks open-label treatment period with milnacipran.
Followed by randomization to 8-weeks double blind treatment period for eligible patients

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
Milnacipran	Experimental	Drug: Milnacipranoral administration, twice daily dosing
Placebo	Placebo comparator	Drug: Placebooral administration, twice daily dosing

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Diagnosis of primary fibromyalgia
13-17 years of age
To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)

Key exclusion criteria (10 listed)

Severe psychiatric illness
Severe renal impairment
Evidence of active liver disease
Pregnant or breastfeeding
Significant risk of suicidality

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
MilnacipranAlso: SavellaMaximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study. Oral administration, twice daily dosing	Drug	Milnacipran
Placebomatching placebo tablets daily	Drug	Placebo

Primary outcome

Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
Time frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances

1 secondary outcome

Patient Global Impression of Severity (PGIS)
Time frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)

Results and safety

Results posted to the registry on 14 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Milnacipran	116	20
Placebo	0	0

Primary outcome: Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.

Time frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16). Mean (Standard Deviation). Unit: Days

Measure	Placebo n = 6	Milnacipran n = 14
Value	NA (NA)	7.0 (1.4)

Population analysed: The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients who were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat \[ITT\] Population).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Event data was collected over a 17-month period from April, 2011 to September, 2012. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Milnacipran - Open-Label Treatment Period	0 of 116 (0%)	62 of 116 (53.4%)	Not reported
Placebo - Double Blind-Treatment	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Milnacipran - Double-Blind Treatment Period	1 of 14 (7.1%)	6 of 14 (42.9%)	Not reported

Limitations and caveats (from the sponsor): Due to the early termination of the study, no firm conclusions about the use of milnacipran in pediatric patients for the treatment of primary fibromyalgia can be drawn.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26112278Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9.

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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.

Patricia M D'Astoli, LPN study director

Forest Laboratories

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Milnacipran in people with Primary Fibromyalgia, run by Forest Laboratories at 47 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 May 2019). 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 First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo. (time frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)). 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 NCT01328002, 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 14 May 2019.