Estudio internacional multicéntrico, doble ciego, aleatorizado, en grupos paralelos, con control histórico, de conversión a monoterapia, para evaluar la eficacia y seguridad de brivaracetam en pacientes (= 16 a 75 años de edad) que sufran crisis de inicio parcial con o sin generalización secundaria.(An international, double-blind, randomized, multi-center, parallel group, historical-control conversion to monotherapy study to evaluate the efficacy and safety of brivaracetam in subjects (= 16 to 75 years old) with partial onset seizures with or without secondary generalization).
- Conditions
- Crisis de inicio parcial con o sin generalización secundaria(Partial onset seizures with or without secondary generalization).MedDRA version: 9.1Level: LLTClassification code 10015037Term: Epilepsy
- Registration Number
- EUCTR2008-000145-58-ES
- Lead Sponsor
- CB Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
• An IEC/IRB approved written informed consent signed and dated by the subject or by parent(s) or legal representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
• Subjects from 16 to 75 years, both inclusive. Subjects under 18 years may only be included where permitted legally and ethically accepted.
• Subjects with a body weight = 45 kg.
• Female subjects without childbearing potential (pre-menarcheal, post-menopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least 30 µg [or 50 µg ethinylestradiol per intake if associated with carbamazepine (or other strong enzyme inducers e.g. oxcarbazepine)] must be used in conjunction with a barrier method. Monogamous relationship with vasectomized partner or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status. Sexual inactivity might be accepted on a case-by-case basis.
• Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
• Well-characterized partial onset seizures according to the ILAE classification (1981) or focal epilepsy or epileptic syndrome according to the ILAE classification (1989).
• Presence of an EEG compatible with the clinical diagnosis of focal epilepsy in the last 5 years. If an EEG has not been performed within the last 5 years, a Baseline EEG must be performed before Visit 3.
• Presence of a brain CT Scan or MRI performed within the last 2 years. If a CT Scan or MRI has not been performed within the last 2 years, a Baseline exam must be performed before Visit 3.
• Subjects with a history of inadequately controlled partial onset seizures that may be classified as simple or complex whether or not secondarily generalized (type I seizures according to the ILAE classification, 1981).
• Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period. (NOTE: Aura is a subjective ictal phenomenon, usually visual, visceral or auditory, that in a given subject may precede an observable seizure. When it occurs by itself it constitutes a simple partial sensory seizure. Auras followed by an observable seizure should only be counted as one event and receive the ILAE code of the observable seizure while stand-alone auras should be counted as a seizure and receive the corresponding ILAE code (1981)).
• Subjects must be on a stable dose of at least 1 but no more than 2 concomitant AEDs for at least 4 weeks before Baseline (Visit 1) and expected to remain on a stable dose until the tapering period commences.
• If a second AED is taken, its dose must be = 50% of the minimum recommended maintenance dose approved in the US for at least 4 weeks before Baseline (Visit 1).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects fo
• Seizure type IA simple partial non-motor as only seizure type.
• History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted, during the 6 months preceding Visit 1 or during Baseline.
• History or presence of status epilepticus during the 1 year preceding Visit 1 or during Baseline.
• History or presence of pseudo-seizures.
• Subjects on felbamate with less than 18 months continuous exposure before Visit 1. Subjects having been on felbamate are eligible if the combined duration of treatment and wash-out is = 18 months.
• Subjects currently on vigabatrin. Subjects having been on vigabatrin if no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or if results of these examinations are abnormal.
• Subjects who have received treatment with phenobarbital or primidone within 3 months prior to Visit 1 and subjects who have received treatment with benzodiazepines within 1 month prior to Visit 1. Subjects with VNS are excluded unless their device has been documented to be inactivated for at least 28 days prior to Visit 1.
• Subjects taking any drug with possible relevant CNS effects except if stable from at least 1 month before Visit 1 and expected to be kept stable during the study.
• Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been kept stable at least one month before Visit 1, and is expected to be kept stable during the study.
• History of cerebrovascular accident (CVA), including transient ischemic attack (TIA), in the last 6 months.
• Subjects suffering from severe cardiovascular disease or peripheral vascular disease.
• Presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (i.e. not expected to stay stable during trial participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable.
• Any clinical conditions (e.g. bone marrow depression, chronic hepatic disease and/or severe renal impairment) which impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
• Presence of a terminal illness.
• Presence of a serious infection.
• Subjects with history of severe adverse hematologic reaction to any drug.
• Subjects suffering from severe disturbance of haemostasis. Impaired hepatic function: ALT/SGPT, AST/SGOT, alkaline phosphatase, gammaGT values of more than three times the upper limit of the reference range. A result of gammaGT exceeding 3 times the upper limit can only be accepted if attributable to hepatic enzyme induction caused by concomitant antiepileptic treatment and other hepatic enzymes are below 3 times the upper limit of the reference range.
• Subjects having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated < 50 mL/min, platelets < 100,000/µL, or neutrophil cells < 1,800/µL).
• Clinically significant ECG abnormalities according to the Investigator.
• History of suicide attempt.
• Ongoing psychiatric disease other than mild controlled disorder.
• Subjects who are institutionalized due to judicial reasons.
• Known allergic reaction or intolerance to pyrrolidone derivatives and/or investigational product excipients (BRV excipients are as follows: Croscarmellose sodium, lactose, beta cyclodextrin, ma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method