Fibromyalgia SyndromePhase 3NCT00757731
FMS European Long-Term Study
A Phase 3 study testing milnacipran in people with Fibromyalgia Syndrome, run by Pierre Fabre Medicament at 10 sites in 10 countries.
Trial summary
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Fibromyalgia Syndrome
- 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
- 490 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Sep 2006to Oct 2008
- 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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who completed the 3-month F02207 GE 302 study
- patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study
Who cannot join
- known hypersensitivity to milnacipran
- major depressive episode
- significant risk of suicide
- generalised anxiety disorder
- substance abuse
- clinically significant cardiac disease
Show all 19Show fewer
- pulmonary dysfunction
- active liver disease
- renal impairment
- autoimmune disease
- current systemic infection
- epileptic
- active cancer
- severe sleep apnoea
- active peptic ulcer
- inflammatory bowel disease
- unstable endocrine disease
- (for men) prostatic enlargement or other genito-urinary disorders
- (for women) pregnancy or breastfeeding
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Germany1 site
KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care
Cologne, D50931
About this study
Official title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Investigation of the long-term (12 months) efficacy and safety of milnacipran used 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
hard capsule
PlaceboDrug
hard capsule
| Study group | Role | What they receive |
|---|---|---|
| Minalcipran 100 mg | Experimental | Not described Receives: Drug: milnacipran; Drug: Placebo |
| Minalcipran 150 mg | Experimental | Not described Receives: Drug: milnacipran; Drug: Placebo |
| Minalcipran 200 mg | Experimental | Not described Receives: Drug: milnacipran; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
Measured: 12 months
Secondary outcomes (1)
To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionOct 2008
- Study completionOct 2008
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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime C BRANCO, MD, Principal investigator, HOSPITAL EGAS MONIZ, Lisboa, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757731
- Sponsor's protocol ID
- F02207 GE 304
- Status last verified
- Jul 2013
- First submitted
- 22 Sep 2008
- Last updated
- 11 Jul 2013
- Results posted
- No
Publications
Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.
PubMed 21459941
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, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00757731
- Acronym / sponsor ID
- F02207 GE 304
- Conditions
- Fibromyalgia Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Sep 2008 (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 the long-term (12 months) efficacy and safety of milnacipran used 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Minalcipran 100 mg | Experimental | Drug: milnacipran, Drug: Placebo |
| Minalcipran 150 mg | Experimental | Drug: milnacipran, Drug: Placebo |
| Minalcipran 200 mg | Experimental | Drug: milnacipran, Drug: Placebo |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient who completed the 3-month F02207 GE 302 study
- patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study
Key exclusion criteria (19 listed)
- known hypersensitivity to milnacipran
- major depressive episode
- significant risk of suicide
- generalised anxiety disorder
- substance abuse
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 |
|---|---|---|
| milnacipranhard capsule | Drug | Minalcipran 100 mg, Minalcipran 150 mg, Minalcipran 200 mg |
| Placebohard capsule | Drug | Minalcipran 100 mg, Minalcipran 150 mg, Minalcipran 200 mg |
Primary outcome
To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
Time frame: 12 months
1 secondary outcome
To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily
Time frame: 12 months
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 21459941Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.
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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.
Jaime C BRANCO, MD principal investigator
HOSPITAL EGAS MONIZ, Lisboa, Portugal
10 sites in 10 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 10 sites in 10 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 2 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 10 sites in Czechia, Finland, France, Germany, Italy and 5 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. 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 assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (time frame: 12 months). 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 NCT00757731, 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.