E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with fibromyalgia syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016631 |
E.1.2 | Term | Fibromyalgia syndrome |
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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 |
The primary objective of this study is to assess the efficacy of Eslicarbazepine Acetate as therapy in patients with fibromyalgia syndrome (FMS). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to assess the safety and tolerability of Eslicarbazepine Acetate in patients with fibromyalgia syndrome (FMS). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is male or female, aged 18 or older. 2. Patient is able and willing to provide written informed consent to participate in the study after having the opportunity to review the Patient Information Sheet and Informed Consent Form (ICF). 3. Patient meets the ACR 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points). 4. Patient is willing and able to understand and comply with all trial requirements, in the judgment of the investigator. 5. Patient has negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the patient at the Screening Visit. 6. Patient use of allowable nonpharmacological therapies must have been stable for at least 4 weeks prior to V1 (Screening Visit) and must be maintained at the stable regimen throughout the study. 7. Female patient is surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least 2 years postmenopausal or, if of childbearing potential, she is sexually abstinent or agrees to use a medically acceptable non-hormonal method of contraception.
Inclusion Criteria at V2 (Randomisation):
8. Patient has negative urine test for drugs of abuse at V2 (Randomisation). 9. Patient must have completed at V2 (Randomisation) at least 4 patient diary pain assessments satisfactorily within the past 7 days and the average pain score must be ≥ 4 and ≤ 9.
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E.4 | Principal exclusion criteria |
1. Patient has a known hypersensitivity to ESL or to other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine) or to any of the excipients. 2. Patient has a history of or current active malignancy except for the following: basal cell carcinoma which has been treated; and malignancies that were successfully treated and have had no recurrence within 5 years before V1 (Screening Visit). 3. Patient has a severe hepatic, renal, respiratory, haematologic, or immunologic illness, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 4. Patient has a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12 lead electrocardiogram (ECG) as determined by the investigator. 5. Patient has a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit). 6. Patient has received an investigational drug (or a medical device) within 3 months of Screening or is currently participating in another trial of an investigational drug (or a medical device) trial. 7. Pregnant or nursing women. 8. Patient is an employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or is a family member of the employees or the investigator. 9. Patient has any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo or hyper thyroidism of any type. 10. Patients whose pain is not due primarily to FMS. 11. Patient underwent tender point injection within 30 days before V1 (Screening Visit) and/or patient is unwilling to refrain from tender point injection throughout the study. 12. Patient has a white blood cell count (WBC) < 2.5 × 10E9/L, neutrophil count < 1.5 × 10E9/L, Na+ < 125 mmol/L, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 × the upper limit of normal at V1 (Screening Visit), or any other clinically relevant laboratory abnormality that, in the investigator’s opinion, can compromise the patient’s safety. 13. Patient has abnormal values for antinuclear antibody (ANA ≥ 1/160) or rheumatoid factor (RF > 15 IU/mL) at V1 (Screening Visit). 14. Patient has abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR > 40 mm/h). 15. Patient has icreatinine clearance lower than 60 mL/min at Screening. 16. Patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥ 35 or a score of 4 or 6 on question 10 of the MADRS at V1 (Screening Visit). 17. Patient used prohibited concomitant medications during the 2 week Baseline Period or used fluoxetine during the 30 days before V1 (Screening Visit). 18. Patient used opiates every day for the 30 days before V1 (Screening Visit) for the control of pain related to FMS. Exclusion criterion at V2: 19. Patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥ 35 or a score of 4 or 6 on question 10 of the MADRS at V2 (Randomisation Visit).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable will be the change from baseline to endpoint in mean pain due to fibromyalgia syndrome. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |