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) |
|
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. |
|
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. |
|
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 |
|
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 |
|
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 | 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 | 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
|
see protocol version 203-00, 2005-06-01 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |