EXTENSION STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN THE RECURRENCE PREVENTION OF BIPOLAR I DISORDEREnsayo de extensión para estudiar la eficacia, seguridad y tolerabilidad de Acetato de Eslicarbazepina (BIA- 2-093) en la prevención de la recurrencia del trastorno bipolar I

BIAL - Portela & Ca, S.A.0 个研究点目标入组 160 人开始时间: 2005年9月21日最近更新: 2021年9月7日

试验速览

暂无简介。

•Patients must be/have:
•1. Informed consent form signed.
•2. Completed the 3-week treatment period in Protocol SCO/BIA-2093-203 or Protocol PRA/BIA-2093-204 and shown response to treatment, defined as a > or equal to 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS < 12.
•3. In the case of women of childbearing potential, the patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception throughout the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients must not be/have
•1. Relevant ECG or laboratory abnormalities.
•2. Any uncontrolled clinically relevant disorder.
•3. Not ensured capability to comply with the study protocol.
•Prohibited therapy during the study period:
•Use of the following medications is prohibited during the study.
•1. Drugs with antimanic properties other than Eslicarbazepine Acetate.
•2. Antidepressants.
•3. Antipsychotic and anxiolytic drugs. Benzodiazepines will be allowed at doses up to 2 mg/day of lorazepam or equivalent (except within 4 hours prior to the YMRS assessments).
•4. Other experimental/investigational drugs.

发起方