A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Start Date
3/11/2021
Completion Date
7/8/2030
Summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Detailed Description
EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Brivaracetam
Conditions
Locations
Ep0156 259
Hawthorne, New York 10532
United States
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Durham, North Carolina 27710
United States
Ep0156 204
Leuven,
Belgium
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Prague,
Czechia
Ep0156 207
Loos,
France
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Freiburg im Breisgau,
Germany
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Budapest,
Hungary
Ep0156 247
Budapest,
Hungary
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Miskolc,
Hungary
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Roma,
Italy
Ep0156 803
Bunkyō City,
Japan
Ep0156 808
Chūō,
Japan
Ep0156 800
Gifu,
Japan
Ep0156 807
Hiroshima,
Japan
Ep0156 815
Kodaira-shi,
Japan
Ep0156 813
Kōshi,
Japan
Ep0156 806
Kyoto,
Japan
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Nagoya,
Japan
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Niigata,
Japan
Ep0156 817
Osaka,
Japan
Ep0156 818
Ōbu,
Japan
Ep0156 819
Ōmura,
Japan
Ep0156 805
Sapporo,
Japan
Ep0156 816
Sendai,
Japan
Ep0156 809
Shimotsuke,
Japan
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Shizuoka,
Japan
Ep0156 804
Tokyo,
Japan
Ep0156 810
Yokohama,
Japan
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Yonago,
Japan
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Aguascalientes,
Mexico
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Culiacán,
Mexico
Ep0156 603
Guadalajara,
Mexico
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Kielce,
Poland
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Krakow,
Poland
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Poznan,
Poland
Ep0156 248
Seville,
Spain