Who is sponsoring NCT01825837?

NCT01825837 is sponsored by Bial - Portela C S.A..

What drugs are being tested in NCT01825837?

Interventions in NCT01825837: BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)], BIA 2-093 300 mg once daily [Group 3 (Part II)], BIA 2-093 900 mg (Part I).

What condition does NCT01825837 study?

NCT01825837 studies Bipolar I Disorder.

Is NCT01825837 still recruiting?

NCT01825837 is currently completed. Last updated 26 February 2014.

Are results published for NCT01825837?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-02-26 · How we verify

NCT01825837

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder

Completed Phase 2 Results posted Last updated 26 February 2014

What this trial tests

Phase 2 trial testing BIA 2-093 1800 mg once daily [Group 1 (Part II)] in Bipolar I Disorder in 104 participants. Completed in 1 June 2007.

Timeline

1 March 2006

Primary endpoint
1 June 2007

1 June 2007

Quick facts

Lead sponsor	Bial - Portela C S.A.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	104
Start date	1 March 2006
Primary completion	1 June 2007
Estimated completion	1 June 2007

Drugs / interventions tested

BIA 2-093 1800 mg once daily [Group 1 (Part II)] — full drug profile →
BIA 2-093 900 mg once daily [Group 2 (Part II)] — full drug profile →
BIA 2-093 300 mg once daily [Group 3 (Part II)] — full drug profile →
BIA 2-093 900 mg (Part I) — full drug profile →

Conditions studied

Bipolar I Disorder — all drugs for Bipolar I Disorder →

Sponsor

Bial - Portela C S.A. — full company profile →

Who can join

Eligibility, any sex, with Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
Time frame: 6 months
The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment. The scale for 'severity of illness' measur

Sponsor's own description

This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bipolar I Disorder

Currently open trials in the same condition.

NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting
NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression · Phase 4 · active not recruiting
NCT06221852 — Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder · NA · recruiting
NCT05648591 — Safety and Tolerability of Open-Labeled Iloperidone in Adolescents · Phase 4 · recruiting
NCT05427123 — Children's Bipolar Network Treatment Trial I · recruiting

Other Bial - Portela C S.A. trials

Trials by the same sponsor.

NCT07403799 — REal-life ON PARKinson's - ITaly (REONPARK-IT) · recruiting
NCT04990284 — eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. · Phase 4 · completed
NCT04986995 — OpicApone Sleep dISorder · Phase 4 · completed
NCT04978597 — Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) · Phase 3 · completed
NCT04986982 — OpiCapone Effect on Motor Fluctuations and pAiN · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01825837 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bial - Portela C S.A.
Last refreshed: 26 February 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01825837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing