This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Status: | Completed |
---|---|
Conditions: | Neurology, Epilepsy |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 12/7/2018 |
Start Date: | January 2006 |
End Date: | September 2017 |
An Open-label, Multi-center, 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 provide
subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive
treatment, the opportunity to receive open label brivaracetam treatment.
subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive
treatment, the opportunity to receive open label brivaracetam treatment.
Study access was limited to subjects having completed one of the previous brivaracetam (BRV)
studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254
[NCT00504881].
studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254
[NCT00504881].
Inclusion Criteria:
- Male/ female subjects from 16 years and on. Subjects under 18 years may only be
included where legally permitted and ethically accepted
- Subjects with epilepsy who have participated in previous brivaracetam trials 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
- Female subjects without childbearing potential. Female subjects with child bearing
potential are eligible if they use a medically accepted contraceptive method for the
duration of the study
- Subject/ legally acceptable representative considered as reliable and capable of
adhering to the protocol, visit schedule or medication intake according to the
judgment of the Investigator
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 the visit schedule or medication intake in the previous
brivaracetam study
- Pregnant or lactating women
- Participation in any clinical study of another investigational drug or device during
the study
We found this trial at
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