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 (#8805; 16 to 75 years old) with partial onset seizures with or without secondary generalization. - ND
- Conditions
- epilepsyMedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsy
- Registration Number
- EUCTR2008-000145-58-IT
- Lead Sponsor
- CB Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 223
1. 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. 2. Subjects from 16 to 75 years, both inclusive. Subjects under 18 years may only be included where permitted legally and ethically accepted. In Germany, only subjects 18 years and older may be included. 3. Subjects with a body weight ≥ 45 kg. 4. 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. 5. 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. 6. Well-characterized partial onset seizures according to the ILAE classification (1981) or focal epilepsy or epileptic syndrome according to the ILAE classification (1989). 7. 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.
ADDITIONAL INCLUSION CRITERIA ON SYNOPSIS
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 for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Seizure type IA simple partial non-motor as only seizure type. 2. 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. 3. History or presence of status epilepticus during the 1 year preceding Visit 1 or during Baseline. 4. History or presence of pseudo-seizures. 5. 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. 6. Subjects currently on vigabatrin. Subjects having been on vigabatrin if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman) or if results of these examinations are abnormal. 7. 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.
ADDITIONAL EXCLUSION CRITERIA ON SYNOPSIS
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