Status:
COMPLETED
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
Lead Sponsor:
UCB PHARMA Inc. (US)
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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 opport...
Detailed Description
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT00150800
Start Date
January 1 2006
End Date
September 1 2017
Last Update
August 17 2021
Active Locations (100)
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1
N01199 1051
Phoenix, Arizona, United States
2
N01199 1362
Phoenix, Arizona, United States
3
N01199 1374
Tucson, Arizona, United States
4
N01199 1050
Little Rock, Arkansas, United States