Fibromyalgia SyndromePhase 2NCT00757679
Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran
A Phase 2 study testing Milnacipran in people with Fibromyalgia Syndrome, run by Pierre Fabre Medicament at 1 site in Switzerland.
Trial summary
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- 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
- 153 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2006to Sep 2009
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with FMS according to the 1990 ACR criteria
- patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
- patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics
Who cannot join
- severe psychiatric illness
- current Major Depressive Episode (MDE)
- significant risk of suicide
- history of substance abuse
- epilepsy
- myocardial infarction in the past 24 months
Show all 29Show fewer
- active cardiac disease
- congestive heart failure
- prosthetic heart valve
- haemodynamically significant valvular heart disease
- known cardiac rhythm anomalies or conduction abnormalities
- unstable and uncontrolled arterial hypertension or supine arterial blood pressure over 160/90 mmHg
- pulmonary dysfunction
- active liver disease
- renal impairment
- documented autoimmune disease
- current systemic infection
- active cancer, except basal cell carcinoma or current cancer therapy
- severe sleep apnoea
- active peptic ulcer or inflammatory bowel disease (except IBS)
- unstable endocrine disease
- pregnancy or breastfeeding
- concomitant use of non selective MAO inhibitors, MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs, NARIs, SNRIs, epinephrine, norepinephrine, clonidine and related compounds, long-acting benzodiazepines
- concomitant use of oral anticoagulants, anticonvulsants, type Ic antiarrythmics, lithium
- concomitant use of hypericum and SAMe
- concomitant use of digitalis preparations
- regular use of centrally-acting muscle relaxants
- concomitant use of strong analgesics, including tramadol, codeine or opiates
- any factor known to affect the HPA axis or autonomic function such as cigarette smoking (regularly over 25 cigarettes a day)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Pharmacology & Toxicology Multidisciplinary Pain Centre
Geneva
About this study
Official title: Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
- 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
capsules
PlaceboDrug
capsules
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran | Experimental | Not described Receives: Drug: Milnacipran |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
Measured: 7 weeks
Secondary outcomes (4)
The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
Measured: 7 weeks
The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
Measured: 7 weeks
The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
Measured: 8 weeks
The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations
Measured: 7 weeks
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 completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jules Desmeules, MD, Principal investigator, Centre Hospitalier HUG Genève - SUISSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757679
- Sponsor's protocol ID
- F02207 GE 205
- Status last verified
- Jul 2013
- First submitted
- 22 Sep 2008
- Last updated
- 11 Jul 2013
- Results posted
- No
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
- Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran. An Exploratory Placebo-controlled Clinical Trial in Fibromyalgia Out-patients
- ClinicalTrials.gov ID
- NCT00757679
- Acronym / sponsor ID
- F02207 GE 205
- Conditions
- Fibromyalgia Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (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.
Evaluation of the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia out-patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Experimental | Drug: Milnacipran |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with FMS according to the 1990 ACR criteria
- patient willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsivants, opiates
- patient willing to discontinue treatment with tender and trigger point injections, joint injections and anesthetics
Key exclusion criteria (29 listed)
- severe psychiatric illness
- current Major Depressive Episode (MDE)
- significant risk of suicide
- history of substance abuse
- epilepsy
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 |
|---|---|---|
| Milnaciprancapsules | Drug | Milnacipran |
| Placebocapsules | Drug | Placebo |
Primary outcome
To assess the antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients.
Time frame: 7 weeks
4 secondary outcomes
The analgesic effect of 7 weeks of treatment with milnacipran, compared to placebo
Time frame: 7 weeks
The correlation of the antinociceptive and analgesic effects of milnacipran with the cytochrome CYP2D6 and COMT phenotype polymorphism determinations
Time frame: 7 weeks
The safety/tolerability and compliance of 8 weeks of treatment with milnacipran
Time frame: 8 weeks
The therapeutic drug monitoring (TDM) and carry out the PK/PD correlations
Time frame: 7 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.
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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.
Jules Desmeules, MD principal investigator
Centre Hospitalier HUG Genève - SUISSE
1 site 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 Fibromyalgia Syndrome, run by Pierre Fabre Medicament at 1 site in Switzerland.
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 29 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 1 site in Switzerland. 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?
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 antinociceptive effect of 7 weeks of treatment with milnacipran, compared to placebo, in fibromyalgia outpatients. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.