EXTENSION STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN THE RECURRENCE PREVENTION OF BIPOLAR I DISORDER

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002134-35-AT

Enrollment

160

Registered

2005-08-23

Start date

2005-09-27

Completion date

Unknown

Last updated

2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrence prevention of bipolar I disorder

Interventions

Product Name: Eslicarbazepine Acetate Product Code: BIA 2-093 Pharmaceutical Form: Tablet Current Sponsor code: BIA 2-093 Other descriptive name: Eslicarbazepine Acetate Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: informed consent form signed; completed the 3-week treatment period in Protocol SCO/BIA-2093-203 or Protocol PRA/BIA-2093-204 and shown response to treatment [i.e., = 50% improvement in the Young Mania Rating Scale (YMRS) total score or an YMRS total score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: relevant ECG or laboratory abnormalities; any uncontrolled clinically relevant disorder; not ensured capability to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of Eslicarbazepine Acetate at three different dosage regimens in the recurrence prevention of bipolar I disorder.;Secondary Objective: To evaluate the safety and tolerability of Eslicarbazepine Acetate as maintenance treatment in patients with bipolar I disorder.;Primary end point(s): Proportion of patients showing no worsening according to Clinical Global Impressions - Bipolar Version (CGI-BP) scale over Part II.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of Eslicarbazepine Acetate at three different dosage regimens in the recurrence prevention of bipolar I disorder.;Secondary Objective: To evaluate the safety and tolerability of Eslicarbazepine Acetate as maintenance treatment in patients with bipolar I disorder.;Primary end point(s): Proportion of patients showing no worsening according to Clinical Global Impressions - Bipolar Version (CGI-BP) scale over Part II.

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Countries

Austria, Czech Republic, Germany, Portugal, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026