- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00957684
Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures
June 23, 2014 updated by: Bial - Portela C S.A.
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial.
This was a phase III 4-part study in multiple centres.
Part I was a 26-week parallel-group, randomised, placebo-controlled period (8 weeks single-blind placebo baseline, 2 weeks double-blind titration, 12 weeks maintenance, and 4 weeks tapering off).
After completing the baseline period, patients were randomised in a 1:1:1:1 ratio to 1 of 3 ESL dose levels or to placebo.
Part II was a 1-year open-label extension for patients who had completed Part I.
The starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals between 400 and 1200 mg.
Part III was an additional 1-year open-label extension for patients who had completed Part II, had participated in the post-Part II study extension, which allowed patients to continue treatment with ESL, or had continued to take ESL in a compassionate use program.
ESL starting doses were the same as received at the end of Part II, during post-Part II study extension, or under compassionate use, and could be titrated up or down at 400-mg intervals between 400 and 1200 mg once daily.
Part IV was a study extension to allow patients to continue ESL treatment after the end of Part III until marketing authorisation or discontinuation of clinical development.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Duration of Treatment: The duration of Part I was 26 weeks: 8 weeks of placebo run-in, 2 weeks of dose titration, 12 weeks of maintenance, and 4 weeks of tapering-off period.
The duration of Part II was 1 year.
The duration of Part III was planned to be 1 year (some patients were treated for >1 year).
The duration of Part IV was >3 years (patients could continue treatment with ESL until market availability).
Study Type
Interventional
Enrollment (Actual)
402
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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S. Mamede do Coronado, Portugal, 4745-457
- Bial - Portela & Cª, S.A.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- written informed consent signed by patient
- aged 18 years or more
- documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
- at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
- excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
- post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method)
Exclusion Criteria:
- only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
- primarily generalised epilepsy
- known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
- seizures of psychogenic origin within the last 2 years
- history of schizophrenia or suicide attempt
- currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
- using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
- previous use of ESL or participation in a clinical study with ESL
- known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
- history of abuse of alcohol, drugs or medications within the last 2 years
- uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
- second or third-degree atrioventricular blockade not corrected with a pacemaker
- relevant clinical laboratory abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESL 400 mg once daily
ESL was supplied in 400-mg and 800-mg tablets
|
once-daily oral tablet
Other Names:
|
Experimental: ESL 800 mg once daily
ESL was supplied in 400-mg and 800-mg tablets
|
once-daily oral tablet
Other Names:
|
Experimental: ESL 1200 mg once daily
ESL was supplied in 400-mg and 800-mg tablets
|
once-daily oral tablet
Other Names:
|
Placebo Comparator: placebo
Placebo matching tablets
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once daily placebo comparator
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Experimental: ESL - PART II
During Part II of the study all patients received Eslicarbazepine Acetate (ESL), including those who had been treated with placebo during Part I. ESL was supplied as scored 800 mg tablets; once daily administration by oral route.
|
once-daily oral tablet
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part I: Seizure Frequency
Time Frame: 12-week maintenance period
|
The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks.
The primary efficacy analysis was based on the intention-to-treat (ITT) population.
Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study.
The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks.
Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to
a "frequency per 4 weeks" basis
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12-week maintenance period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prof. Christian Elger, Department of Epileptology, Friedrich Wilhelms University Bonn
- Principal Investigator: Prof. Peter Halasz, National Institute of Psychiatry and Neurology, Budapest, Hungary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 11, 2009
First Posted (Estimate)
August 12, 2009
Study Record Updates
Last Update Posted (Estimate)
July 2, 2014
Last Update Submitted That Met QC Criteria
June 23, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Epilepsy
- Seizures
- Epilepsies, Partial
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Eslicarbazepine acetate
Other Study ID Numbers
- BIA-2093-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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