Refractory Partial Epilepsy Clinical Trial
Official title:
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.
| Verified date | June 2014 |
| Source | Bial - Portela C S.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Portugal: National Pharmacy and Medicines Institute |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | February 2007 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Bial - Portela & Cª, S.A. | S. Mamede do Coronado |
| Lead Sponsor | Collaborator |
|---|---|
| Bial - Portela C S.A. |
Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part I: Seizure Frequency | 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 | 12-week maintenance period | No |