E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain, widespread tenderness and fatigue. The disorder is well defined in the USA, where the current diagnosis of FMS is based on the criteria set forth by the American College of Rheumatology (ACR) in 19901.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of 12 weeks of treatment with Milnacipran on sensitivity to stimulus-evoked pain in out-patients with fibromyalgia syndrome. |
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E.2.2 | Secondary objectives of the trial |
To assess the correlation between the effect of Milnacipran on sensitivity to stimulus-evoked pain and findings on functional Magnetic Resonance Imaging (fMRI). To identify baseline measures that predict response to treatment. To assess the safety and tolerability of 12 weeks of treatment with Milnacipran. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients who have Fibromyalgia according to the 1990 ACR criteria and recruited from primary care. 2. Female patients between the ages of 18 and 55 years. 3. Right-handed. 4. Females must be either postmenopausal (no menses for at least 1 year) or status-post hysterectomy or oophorectomy (bilateral) or, if of childbearing potential, must have a negative urine pregnancy test prior randomization, and be using a medically acceptable form of contraception for about two months before the inclusion in this study (i.e., hormonal birth control, IUD), The contraception should be continued one month after the intake of the last dose of study treatment. 5. Patients must have the ability to give informed consent. 6. Patients must be willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsants, mood stabilizers, opioids, narcotic patches 7. Patients must be willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender and trigger point injections, acupuncture, and anesthetic. 8. Patients must have a VAS intensity pain scale over last week before randomisation of at least 40 on a 0-100mm scale at baseline |
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E.4 | Principal exclusion criteria |
For all patients with severe physical impairment (e.g., bilateral amputation, complete blindness or deafness), medical conditions that were capable of causing patients’ symptoms (e.g., morbid obesity, autoimmune/inflammatory diseases), cardiopulmonary disorders (i.e., angina pectoris, congestive heart failure, COPD, chronic asthma), arterial hypertension, hepatic or chronic renal insufficiency, uncontrolled endocrine or allergic disorders (i.e., hyper-/hypothyroidism, diabetes, allergic rhinitis), malignancy, severe psychiatric illnesses (e.g., current schizophrenia, current major depressive episode), substance abuse within the past two years)Patient with abnormal standard ECG at screening Patient with intracranial anomaly during the first fMRI session Patient who is receiving concomitant drug therapy included in the table in appendix 17.6 of the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in pain perception: shift of the stimulus-response curves (Pressure-pain sensitivity by subjective scaling of multiple pressure-pain sensations of suprathreshold intensities) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |