Fibromyalgia SyndromePhase 3NCT00436033
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
A Phase 3 study testing milnacipran in people with Fibromyalgia Syndrome, run by Pierre Fabre Medicament at 13 sites in 13 countries.
Trial summary
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- milnacipran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,429 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Feb 2006to Sep 2007
- 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
- patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria
Who cannot join
- psychiatric illness
- depression of generalised anxiety disorder
- suicidal risk
- substance abuse
- active cardiac disease
- pulmonary dysfunction
Show all 19Show fewer
- liver disease
- renal impairment
- autoimmune disease
- chronic inflammatory rheumatoid disease
- current systemic infection
- epileptic
- active cancer
- sleep apnea
- active peptic ulcer
- inflammatory bowel disease
- unstable endocrine disease
- for men : prostatic enlargement of genito-urinary disorders
- for women : pregnancy or breast feeding
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
Denmark1 site
FREDERIKSBERG HOSPITAL - Clinic of Rheumatology
Frederiksberg, F2000
Germany1 site
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Cologne, D50931
United Kingdom1 site
KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology
London, SE59RJ
About this study
Official title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- milnacipran, Placebo
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milnacipranDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Minalcipran | Experimental | Not described Receives: Drug: milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion
Measured: 12 weeks
Secondary outcomes (2)
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
Measured: 12 weeks
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionSep 2007
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 Fibromyalgia SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Jaime C BRANCO, Principal investigator, HOSPITAL EGAS MONIZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436033
- Sponsor's protocol ID
- F02207GE302
- Status last verified
- Jul 2013
- First submitted
- 15 Feb 2007
- Last updated
- 11 Jul 2013
- Results posted
- No
Publications
Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.
PubMed 20156949
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00436033
- Acronym / sponsor ID
- F02207GE302
- Conditions
- Fibromyalgia Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,429 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Feb 2007 (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.
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Minalcipran | Experimental | Drug: milnacipran |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria
Key exclusion criteria (19 listed)
- psychiatric illness
- depression of generalised anxiety disorder
- suicidal risk
- substance abuse
- 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 |
|---|---|---|
| milnacipran | Drug | Minalcipran |
| Placebo | Drug | Placebo |
Primary outcome
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion
Time frame: 12 weeks
2 secondary outcomes
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria
Time frame: 12 weeks
establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).
Time frame: 19 weeks
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 11 Jul 2013.
- Derived from this study: PubMed 20156949Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.
Related trials for Fibromyalgia Syndrome
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.
Dr Jaime C BRANCO principal investigator
HOSPITAL EGAS MONIZ
13 sites in 13 countries: 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 Syndrome, run by Pierre Fabre Medicament at 13 sites in 13 countries.
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 19 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Czechia, Denmark, Finland, France, Germany and 8 more countries. 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?
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?
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (time frame: 12 weeks). 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 NCT00436033, 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 11 Jul 2013.