E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute manic episode fulfilling DSM-IV criteria for Bipolar I Disorder (i.e., 296.0, 296.4 or 296.6) |
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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 evaluate the dose-dependent efficacy of two dose titration regimens of Eslicarbazepine Acetate compared with placebo as therapy in patients with acute mania. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of two dose titration regimens of Eslicarbazepine Acetate in comparison to placebo. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- 18 years or more - DSM-IV criteria for Bipolar I Disorder (i.e., 296.0, 296.4 or 296.6) and for current acute manic (including mixed) episode - YMRS total score ≥ 20 - symptoms of current manic episode starting within 2 weeks prior to Randomisation - able to undergo a standard evaluation including clinical interview, ratings and laboratory studies - signed informed consent form (ICF) - post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation - in case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception until at least the post-study visit
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E.4 | Principal exclusion criteria |
- history of schizophrenia or schizoaffective disorder - psychotic features, history of rapid cycling; currently treated with carbamazepine or oxcarbazepine - history of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine) - use of depot-neuroleptics in the current manic episode, abuse of stimulating drugs or use of systemic sympathicomimetic drugs within the previous 2 weeks - electroconvulsive therapy (ECT) within the previous 3 months - history of dependence or chronic abuse from alcohol, drugs or medications within the last year - clinically judged to be at risk of harm to self or others; second or third-degree atrioventricular blockade not corrected with a pacemaker - relevant ECG or laboratory abnormalities - calculated creatinine clearance < 30 mL/min- pregnancy or nursing - participation in other drug clinical trial within the last 2 months before randomization visit - not ensured capability to perform the trial or to comply with the study protocol (e.g. mental retardation or severe inability to communicate) - any other uncontrolled clinically relevant disorder - previous treatment with study drug Eslicarbazepine acetate (BIA 2-093) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in the YMRS score at the end of the 3-week treatment period, in the relation to the baseline |
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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 | Information not present in EudraCT |
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.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |