Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01339559
Eligibility Criteria:
Inclusion Criteria:
* Subject completed the Treatment Period of N01358 or the evaluation period of N01258
* Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
* Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
* Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
Exclusion Criteria:
* Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
* Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous BRV study
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the Investigator's opinion, warrants exclusion
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01339559
Study Brief:
Protocol Section:
NCT01339559