A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Study Purpose

The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male/female study participant from 16 years of age or older.
Study participant who are not legal adults may only be included where legally permitted and ethically accepted.
  • - Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan.
  • - Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method.
  • - Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration.

Exclusion Criteria:

  • - Study participant 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 study.
  • - Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant.
  • - Poor compliance with the visit schedule or medication intake in the previous BRV studies.
  • - 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.
  • - Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months.
- Study participant has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03250377
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries China, Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Partial Seizures With or Without Secondary Generalization, Epilepsy
Arms & Interventions

Arms

Experimental: Brivaracetam

Subjects randomized to this arm will receive open-label Brivaracetam

Interventions

Drug: - Brivaracetam

- Pharmaceutical form: Film-coated tablet - Concentration: 25 mg and 50 mg - Route of administration: Oral use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ep0085 905, Beijing, China

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Ep0085 905

Beijing, ,

Ep0085 901, Chengdu, China

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Ep0085 901

Chengdu, ,

Ep0085 902, Guangzhou, China

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Ep0085 902

Guangzhou, ,

Ep0085 909, Guangzhou, China

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Ep0085 909

Guangzhou, ,

Ep0085 917, Guangzhou, China

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Ep0085 917

Guangzhou, ,

Ep0085 920, Guangzhou, China

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Ep0085 920

Guangzhou, ,

Ep0085 924, Guangzhou, China

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Ep0085 924

Guangzhou, ,

Ep0085 912, Hangzhou, China

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Ep0085 912

Hangzhou, ,

Ep0085 908, Lanzhou, China

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Ep0085 908

Lanzhou, ,

Ep0085 921, Nanchang, China

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Ep0085 921

Nanchang, ,

Ep0085 926, Pingxiang, China

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Ep0085 926

Pingxiang, ,

Ep0085 910, Shijiazhuang, China

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Ep0085 910

Shijiazhuang, ,

Ep0085 925, Suzhou, China

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Ep0085 925

Suzhou, ,

Ep0085 913, Wenzhou, China

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Ep0085 913

Wenzhou, ,

Ep0085 930, Xinxiang, China

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Ep0085 930

Xinxiang, ,

Ep0085 916, Yinchuan, China

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Ep0085 916

Yinchuan, ,

Ep0085 918, Zhanjiang, China

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Ep0085 918

Zhanjiang, ,

Ep0085 904, Zhengzhou, China

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Ep0085 904

Zhengzhou, ,

Ep0085 923, Zunyi, China

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Ep0085 923

Zunyi, ,

Ep0085 148, Adachi-ku, Japan

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Ep0085 148

Adachi-ku, ,

Ep0085 116, Asaka, Japan

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Ep0085 116

Asaka, ,

Ep0085 126, Bunkyo-ku, Japan

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Ep0085 126

Bunkyo-ku, ,

Ep0085 127, Bunkyo-ku, Japan

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Ep0085 127

Bunkyo-ku, ,

Ep0085 122, Hachinohe, Japan

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Ep0085 122

Hachinohe, ,

Ep0085 111, Hamamatsu, Japan

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Ep0085 111

Hamamatsu, ,

Ep0085 141, Higashisonogi-gun Kawatana-cho, Japan

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Ep0085 141

Higashisonogi-gun Kawatana-cho, ,

Ep0085 110, Hiroshima-shi, Japan

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Ep0085 110

Hiroshima-shi, ,

Ep0085 121, Itami, Japan

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Ep0085 121

Itami, ,

Ep0085 102, Kagoshima, Japan

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Ep0085 102

Kagoshima, ,

Ep0085 142, Kamakura, Japan

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Ep0085 142

Kamakura, ,

Ep0085 140, Kawasaki, Japan

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Ep0085 140

Kawasaki, ,

Ep0085 123, Kodaira, Japan

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Ep0085 123

Kodaira, ,

Ep0085 115, Kokubunji, Japan

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Ep0085 115

Kokubunji, ,

Ep0085 132, Koriyama, Japan

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Ep0085 132

Koriyama, ,

Ep0085 112, Koshi, Japan

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Ep0085 112

Koshi, ,

Ep0085 128, Kurume, Japan

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Ep0085 128

Kurume, ,

Ep0085 124, Kyoto, Japan

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Ep0085 124

Kyoto, ,

Ep0085 147, Kyoto, Japan

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Ep0085 147

Kyoto, ,

Ep0085 105, Nagakute, Japan

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Ep0085 105

Nagakute, ,

Ep0085 118, Nagoya, Japan

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Ep0085 118

Nagoya, ,

Ep0085 136, Nagoya, Japan

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Ep0085 136

Nagoya, ,

Ep0085 117, Nara, Japan

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Ep0085 117

Nara, ,

Ep0085 129, Neyagawa, Japan

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Ep0085 129

Neyagawa, ,

Ep0085 106, Niigata, Japan

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Ep0085 106

Niigata, ,

Ep0085 850, Osaka, Japan

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Ep0085 850

Osaka, ,

Ep0085 131, Otsu, Japan

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Ep0085 131

Otsu, ,

Ep0085 114, Saitama, Japan

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Ep0085 114

Saitama, ,

Ep0085 101, Sapporo, Japan

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Ep0085 101

Sapporo, ,

Ep0085 103, Sendai, Japan

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Ep0085 103

Sendai, ,

Ep0085 144, Shinjuku-ku, Japan

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Ep0085 144

Shinjuku-ku, ,

Ep0085 104, Shizuoka, Japan

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Ep0085 104

Shizuoka, ,

Ep0085 108, Suita, Japan

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Ep0085 108

Suita, ,

Ep0085 137, Suita, Japan

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Ep0085 137

Suita, ,

Ep0085 138, Tsukuba, Japan

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Ep0085 138

Tsukuba, ,

Ep0085 133, Ushiku, Japan

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Ep0085 133

Ushiku, ,

Ep0085 109, Yamagata, Japan

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Ep0085 109

Yamagata, ,

Ep0085 120, Yokohama, Japan

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Ep0085 120

Yokohama, ,

Ep0085 150, Yokohama, Japan

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Ep0085 150

Yokohama, ,

Ep0085 130, Ôsaka, Japan

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Ep0085 130

Ôsaka, ,

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