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BIPOLAR I DISORDERPhase 2NCT01824602

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

A Phase 2 study testing Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg and Eslicarbazepine acetate 600 mg in people with BIPOLAR I DISORDER, run by Bial - Portela C S.A..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
BIPOLAR I DISORDER
What is being tested?
Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg and Eslicarbazepine acetate 600 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
No sites listed yet
Study dates
Feb 2006to Nov 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or more.
  • A documented diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (i.e., 296.0, 296.4 or 296.6).
  • Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria.
  • A Young Mania Rating Scale (YMRS) total score of 20 or greater.
  • Symptoms of the current manic episode starting within 2 weeks prior to Randomization (V2, Day 1).
  • 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 (PSV).

Who cannot join

  • History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling.
  • Currently treated with carbamazepine or oxcarbazepine.
  • History of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine).
  • Use of any depot-neuroleptics for the current manic episode
  • Abuse of stimulating drugs or use of any systemic sympathicomimetic drug within the previous 2 weeks.
  • Electroconvulsive therapy (ECT) within the previous 3 months
Show all 16Show fewer
  • History of dependence or chronic abuse from alcohol, drugs or medications within the last year.
  • Judged clinically 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 [men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dl].
  • 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 Eslicarbazepine Acetate.

About this study

Official title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder in a Double-blind, Fixed Multiple Dose, Randomised, Placebo-controlled,Multicentre Clinical Trial.

The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093) administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration to onset of action in the different dose groups, and c) monitor the appearance of depressive symptoms.

Read the detailed description

This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks. On Day 10, patients who showed no improvement were switched to open-label escape therapy with an established antimanic therapy. Patients could have been hospitalized at screening or at any time during the study at the investigator's discretion. Following randomisation (V2, Day 1), patients were assessed on Days 3, 7, 10, 14, 21, 28, and 56, after which they could either enter a recurrence prevention study, or the study drug could be tapered off and they could undergo follow-up assessments.

Being tested
Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg, Eslicarbazepine acetate 600 mg, Placebo
Keywords
BIPOLAR I DISORDER, Eslicarbazepine acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eslicarbazepine acetate 1800 mgDrug

    Also called Esl

    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

  • Eslicarbazepine acetate 1200 mgDrug

    Also called Esl

    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

  • Eslicarbazepine acetate 600 mgDrug

    Also called Esl

    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

  • PlaceboDrug

    Also called Placebo sugar pills

    Placebo sugar pills

Study groups in NCT01824602
Study groupRoleWhat they receive
Group 1ExperimentalEslicarbazepine acetate 1800 mg
Receives: Drug: Eslicarbazepine acetate 1800 mg
Group 2ExperimentalEslicarbazepine acetate 1200 mg
Receives: Drug: Eslicarbazepine acetate 1200 mg
Group 3ExperimentalEslicarbazepine acetate 600 mg
Receives: Drug: Eslicarbazepine acetate 600 mg
Group 4Placebo comparatorPlacebo pills
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period

    The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.

    Measured: baseline and 3-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2013 (estimated)
  2. Study startFeb 2006
  3. Primary completionNov 2006
  4. Study completionNov 2006

Why it stopped: Due to a slow recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01824602
Sponsor's protocol ID
BIA-2093-204
Status last verified
Aug 2013
First submitted
28 Mar 2013
Last updated
27 Mar 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eslicarbazepine acetate 1800 mg, Eslicarbazepine acetate 1200 mg and Eslicarbazepine acetate 600 mg in people with BIPOLAR I DISORDER, run by Bial - Portela C S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period (time frame: baseline and 3-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01824602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.

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