E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065336 |
E.1.2 | Term | Partial epilepsy |
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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 |
To evaluate the one-year safety and tolerability of eslicarbazepine acetate flexible dosing within the range of 800 mg to 2400 mg in subjects with partial epilepsy who have participated in an 18-week double-blind eslicarbazepine acetate monotherapy study (Protocols 093-045 or 093-046). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the maintenance of the therapeutic effects of eslicarbazepine acetate over a one-year open-label period. To evaluate the health-related quality of life, suicidality, and depressive symptoms over a one-year open label period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible. 2.Subject must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject’s parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the “Women of Childbearing Potential” Addendum. 3.Subject must continue to meet the inclusion and not meet the exclusion criteria defined in Protocols 093-045 or 093-046 and not present with any safety concerns (as determined by the Investigator). 4.If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well. |
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E.4 | Principal exclusion criteria |
1.Subject with serum sodium level ≤125 mmol/L. 2.Subject with any kind of hypersensitivity (especially manifested as rash) suspected to be induced by eslicarbazepine, carbamazepine, oxcarbazepine, or chemically-related substances. 3.Subject who needs to initiate prohibited concomitant medications. 4.Subject who needs to reduce eslicarbazepine acetate dose to <800 mg QD or increase dose to >2400 mg QD. 5.Subject who needs to use >2 additional AEDs. If applicable, provide sufficient study drug to taper subject off of study drug (taper schedule is at the Investigator’s discretion). Schedule a follow-up (unscheduled) visit, if applicable, to assess AEs and to collect all remaining study drug in the original container (including any empty containers). Please also refer to Section 12, Discontinuation and Replacement of Subjects. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Clinical evaluations (adverse events, vital signs, orthostatic effects, physical and full neurological examination, body weight, and 12-lead ECGs). 2.Clinical laboratory evaluations (serum chemistry, hematology and urinalysis), high-density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol, and triglycerides), coagulation testing (PT/INR, and PTT), bone turnover markers (serum 25-hydroxyvitamin D [25-OHD], parathyroid hormone [PTH], osteocalcin, bone-specific alkaline phosphatase, and urinary N-telopeptides of type I collagen cross-links [NTx]). 3.Proportion (%) of subjects with increase of body weight ≥7%. 4.Proportion (%) of subjects with normal baseline blood sodium reaching levels of ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L. 5.Columbia Suicidality Severity Rating Scale (C-SSRS). 6.Time on eslicarbazepine acetate monotherapy. 7.Seizure frequency reduction from baseline period (Visit 1 to 2) of Protocols 093-045 or 093-046. 8.Responder rate (proportion [%] of subjects with a ≥50% reduction of seizure frequency from baseline period [Visit 1 to 2] of Protocols 093-045 or 093-046). 9.Proportion (%) of subjects seizure-free during study (determined in 12-week intervals). 10.Seizure frequency by seizure type. 11.Completion rate (proportion [%] of subjects completing the one-year treatment). 12.Treatment retention time (time to withdrawal due to lack of efficacy or adverse events). 13.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in 31-Item Quality of Life in Epilepsy (QOLIE-31). 14.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in Montgomery-Asberg Depression Rating Scale (MADRS). 15.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in MADRS in those subjects with a MADRS score of ≥14 at screening visit of the present study. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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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Described in the protocol |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |