Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 3/24/2019 |
| Start Date: | September 2005 |
| End Date: | May 2019 |
An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
This trial, evaluating the long-term safety and tolerability of brivaracetam, will give
subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity
to continue the treatment. The study will also evaluate the maintenance of efficacy over time
of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures
(PGS).
subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity
to continue the treatment. The study will also evaluate the maintenance of efficacy over time
of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures
(PGS).
Inclusion Criteria:
- Male/female subjects from 16 years (where legally permitted and ethically accepted) or
18 years onwards suffering from epilepsy and having completed a previous study with
brivaracetam as adjunctive treatment, which allowed access to this study
- Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in
previous brivaracetam studies / programs which allow access to the present study
- Subjects with ULD: inpatients or outpatients with epilepsy who were treated with
brivaracetam in previous studies / programs which allow access to the present study
- Subjects for whom the Investigator believes a reasonable benefit from the long-term
administration of brivaracetam may be expected
Exclusion Criteria:
- Severe medical, neurological and psychiatric disorders, or laboratory values which may
have an impact on the safety of the subject
- Poor compliance with visit schedule or medication intake in previous brivaracetam
study
- Participation in any clinical study of another investigational drug or device during
the study
- Pregnant or lactating woman
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