FibromylagiaPhase 2NCT01747044
Prospective Study of the Influence of the Diffuse Noxious Inhibitory Controls of the Pain on the Efficacy of Milnacipran in Fibromyalgia Therapy
A Phase 2 study testing Milnacipran in people with Fibromylagia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromylagia
- What is being tested?
- Milnacipran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Nov 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of more than 18 years old,
- Patient with fibromyalgia
Who cannot join
- Patient with a contraindication to the administration of the milnacipran,
- Patient with a concomitant spontaneous pain not attributable of fibromyalgia,
- Patient with medical and/or surgical histories judged by the investigator not compatible with the trial.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al.
The definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR classification. Several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia.
Read more
According to the Recommendations of the European League Against Rheumatism (EULAR) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR. A review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" Impression and global change. Substantial improvement with milnacipran compared to placebo has been shown.
To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug treatment has not been shown.
This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be predictive of the efficacy of milnacipran.
Read the detailed description
Visit 1 Inclusion of the patient, Clinical examination, Evaluation of pain, basal Pain and cognitive tests
Visit 2 (can be coupled with Visit 1 if necessary) Randomisation of the patient and allocation of the treatment for 1 month.
Phone contact Visit 2 +7 days, + 15 days, +21 days Follow-up of the compliance of the treatment and collection of adverse events.
Visit 3 (follow up at 1 month) Evaluation of pain, Pain and cognitive tests End of study
- Conditions
- Fibromylagia
- Being tested
- Milnacipran, Placebo
- Keywords
- Fibromyalgia, Diffuse Noxious Inhibitory Controls, Milnacipran
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
100mg/day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran | Active comparator | Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR Receives: Drug: Milnacipran |
| Capsules of lactose | Placebo comparator | placebo over a period of 8 weeks to 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the verbal numeric scale
Measured: at T0 and T0+1 month
Secondary outcomes (4)
sensitivity and pain thresholds to a mechanical stimulus
Measured: at T0 and T0+1 month
sensitivity and pain thresholds to a thermal stimulus
Measured: at T0 and T0+1 month
scores on cognitive tests
Measured: at T0 and T0+1 month
Adverse events record
Measured: at T0 and T0+1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
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 FibromylagiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-501 - Main investigator, Dr Pascale PICARD/ Dr Noémie Delage / Dr Fabienne RIAUX - Center of evaluation and treatment of the pain - Investigator, Dr Gilles DUCHEIX/ Center of clinical pharmacology/CIC Inserm-501 - Investigator, Dr Christian DUALE/ Center of clinical pharmacology/CIC Inserm-501 - Investigator
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747044
- Sponsor's protocol ID
- CHU-0130
- Status last verified
- Jul 2014
- First submitted
- 27 Nov 2012
- Last updated
- 8 Jul 2014
- Results posted
- No
Publications
Macian N, Pereira B, Shinjo C, Dubray C, Pickering G. Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial. Trials. 2015 Apr 3;16:134. doi: 10.1186/s13063-015-0659-4.
PubMed 25873248
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Influence of the Diffuse Noxious Inhibitory Controls of the Pain on the Efficacy of Milnacipran in Fibromyalgia Therapy
- ClinicalTrials.gov ID
- NCT01747044
- Acronym / sponsor ID
- CHU-0130
- Conditions
- Fibromylagia
- Keywords
- Fibromyalgia, Diffuse Noxious Inhibitory Controls, Milnacipran
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-501 - Main investigator, Dr Pascale PICARD/ Dr Noémie Delage / Dr Fabienne RIAUX - Center of evaluation and treatment of the pain - Investigator, Dr Gilles DUCHEIX/ Center of clinical pharmacology/CIC Inserm-501 - Investigator, Dr Christian DUALE/ Center of clinical pharmacology/CIC Inserm-501 - Investigator
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 Dec 2012 (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.
Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al.
The definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR classification. Several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia.
According to the Recommendations of the European League Against Rheumatism (EULAR) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR. A review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" Impression and global change. Substantial improvement with milnacipran compared to placebo has been shown.
To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug treatment has not been shown.
This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be predictive of the efficacy of milnacipran.
Detailed description
Visit 1 Inclusion of the patient, Clinical examination, Evaluation of pain, basal Pain and cognitive tests
Visit 2 (can be coupled with Visit 1 if necessary) Randomisation of the patient and allocation of the treatment for 1 month.
Phone contact Visit 2 +7 days, + 15 days, +21 days Follow-up of the compliance of the treatment and collection of adverse events.
Visit 3 (follow up at 1 month) Evaluation of pain, Pain and cognitive tests End of study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Active comparator | Drug: MilnacipranMilnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR |
| Capsules of lactose | Placebo comparator | Drug: Placeboplacebo over a period of 8 weeks to 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient of more than 18 years old,
- Patient with fibromyalgia
Key exclusion criteria (3 listed)
- Patient with a contraindication to the administration of the milnacipran,
- Patient with a concomitant spontaneous pain not attributable of fibromyalgia,
- Patient with medical and/or surgical histories judged by the investigator not compatible with the trial.
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 |
|---|---|---|
| Milnacipran100mg/day | Drug | Milnacipran |
| Placebo | Drug | Capsules of lactose |
Primary outcome
Pain scores on the verbal numeric scale
Time frame: at T0 and T0+1 month
4 secondary outcomes
sensitivity and pain thresholds to a mechanical stimulus
Time frame: at T0 and T0+1 month
sensitivity and pain thresholds to a thermal stimulus
Time frame: at T0 and T0+1 month
scores on cognitive tests
Time frame: at T0 and T0+1 month
Adverse events record
Time frame: at T0 and T0+1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Derived from this study: PubMed 25873248Macian N, Pereira B, Shinjo C, Dubray C, Pickering G. Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial. Trials. 2015 Apr 3;16:134. doi: 10.1186/s13063-015-0659-4.
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.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
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 Fibromylagia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2014. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores on the verbal numeric scale (time frame: at T0 and T0+1 month). 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 NCT01747044, 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 8 Jul 2014.