FibromyalgiaPhase 3NCT00793520

Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

A Phase 3 study testing Milnacipran in people with Fibromyalgia, run by Forest Laboratories at 1 site in United States.

Terminated

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

Trial summary

The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Apr 2009
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
Visual analog pain score between 40 and 90 mm
Right-hand dominance

Who cannot join

Suicidal risk
Substance Abuse
Pulmonary dysfunction
Renal impairment
Active cardiac disease
Autoimmune disease

Show all 12Show fewer

Uncontrolled narrow-angle glaucoma
Active liver disease
Cancer
Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue
Unstable endocrine disease
Prostatic enlargement

Trial locations and contacts

1 site in 1 country.

United States1 site

Forest Investigative Site
Ann Arbor, Michigan, 48106

Other trials in United States

About this study

Conditions: Fibromyalgia
Being tested: Milnacipran, Placebo
Keywords: fibromyalgia, milnacipran, Forest Laboratories
Medical subject headings: Fibromyalgia

What participants receive

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

MilnacipranDrug
Twice daily oral administration of Milnacipran for 5 weeks.
PlaceboDrug
Twice daily oral administration of placebo for 5 weeks.
PlaceboDrug
Twice daily oral administration of placebo for 5 weeks.
MilnacipranDrug
Twice daily oral administration of Milnacipran for 5 weeks.

Study groups in NCT00793520
Study group	Role	What they receive
1	Experimental	Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. Receives: Drug: Milnacipran; Drug: Placebo
2	Experimental	Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. Receives: Drug: Placebo; Drug: Milnacipran

What is being measured

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

Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.
Measured: Week 0, 5, 7 and 12

Secondary outcomes (1)

Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 \& 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC
Measured: Weeks 0, 5, 7 and 12

Timeline

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

Nov 2008Apr 2009

First posted19 Nov 2008 (estimated)
Study startNov 2008
Primary completionApr 2009

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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00793520
Sponsor's protocol ID: MLN-MD-16
Status last verified: Jun 2010
First submitted: 17 Nov 2008
Last updated: 1 Jul 2010
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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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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Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00793520
Acronym / sponsor ID: MLN-MD-16
Conditions: Fibromyalgia
Keywords: fibromyalgia, milnacipran, Forest Laboratories
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 2 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Apr 2009 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 1 Jul 2010

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Milnacipran, Drug: PlaceboTwice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
2	Experimental	Drug: Placebo, Drug: MilnacipranTwice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.

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
Visual analog pain score between 40 and 90 mm
Right-hand dominance

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
MilnacipranTwice daily oral administration of Milnacipran for 5 weeks.	Drug	1
PlaceboTwice daily oral administration of placebo for 5 weeks.	Drug	2
PlaceboTwice daily oral administration of placebo for 5 weeks.	Drug	1
MilnacipranTwice daily oral administration of Milnacipran for 5 weeks.	Drug	2

Primary outcome

Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
Time frame: Week 0, 5, 7 and 12
Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.

1 secondary outcome

Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Time frame: Weeks 0, 5, 7 and 12

Results and safety

Results posted to the registry on 1 Jul 2010, 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 to Placebo	1	0
Placebo to Placebo	0	0

Primary outcome: Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.

Time frame: Week 0, 5, 7 and 12. Mean (95% Confidence Interval). Unit: Kg

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Milnacipran	0 of 1 (0%)	1 of 1 (100%)	Not reported
Placebo	0 of 1 (0%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects enrolled. Technical problems with MRI equipment resulted in early study termination. No analysis was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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.

Allan Spera study director

Forest Research Institute, a subsidiary of Forest Laboratories Inc

1 site 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 in people with Fibromyalgia, run by Forest Laboratories at 1 site 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: stopped early, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 Jul 2010). 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?

Change in Medium Pressure Pain Threshold From Baseline to End of Treatment. (time frame: Week 0, 5, 7 and 12). 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 NCT00793520.

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 1 Jul 2010.