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

Epilepsy Clinical Trial

Official title:

An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03250377
• Other study ID #: EP0085
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 5, 2017
• Est. completion date: March 3, 2025

Study information

• Verified date: May 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 217
• Est. completion date: March 3, 2025
• Est. primary completion date: March 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Neoplasm Metastasis
• Partial Seizures With or Without Secondary Generalization
• Seizures

Intervention

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

Locations

Country	Name	City	State
China	Ep0085 905	Beijing
China	Ep0085 901	Chengdu
China	Ep0085 902	Guangzhou
China	Ep0085 909	Guangzhou
China	Ep0085 917	Guangzhou
China	Ep0085 920	Guangzhou
China	Ep0085 924	Guangzhou
China	Ep0085 912	Hangzhou
China	Ep0085 908	Lanzhou
China	Ep0085 921	Nanchang
China	Ep0085 926	Pingxiang
China	Ep0085 910	Shijiazhuang
China	Ep0085 925	Suzhou
China	Ep0085 913	Wenzhou
China	Ep0085 930	Xinxiang
China	Ep0085 916	Yinchuan
China	Ep0085 918	Zhanjiang
China	Ep0085 904	Zhengzhou
China	Ep0085 923	Zunyi
Japan	Ep0085 148	Adachi-ku
Japan	Ep0085 116	Asaka
Japan	Ep0085 126	Bunkyo-ku
Japan	Ep0085 127	Bunkyo-ku
Japan	Ep0085 122	Hachinohe
Japan	Ep0085 111	Hamamatsu
Japan	Ep0085 141	Higashisonogi-gun Kawatana-cho
Japan	Ep0085 110	Hiroshima-shi
Japan	Ep0085 121	Itami
Japan	Ep0085 102	Kagoshima
Japan	Ep0085 142	Kamakura
Japan	Ep0085 140	Kawasaki
Japan	Ep0085 123	Kodaira
Japan	Ep0085 115	Kokubunji
Japan	Ep0085 132	Koriyama
Japan	Ep0085 112	Koshi
Japan	Ep0085 128	Kurume
Japan	Ep0085 124	Kyoto
Japan	Ep0085 147	Kyoto
Japan	Ep0085 105	Nagakute
Japan	Ep0085 118	Nagoya
Japan	Ep0085 136	Nagoya
Japan	Ep0085 117	Nara
Japan	Ep0085 129	Neyagawa
Japan	Ep0085 106	Niigata
Japan	Ep0085 850	Osaka
Japan	Ep0085 130	Ôsaka
Japan	Ep0085 131	Otsu
Japan	Ep0085 114	Saitama
Japan	Ep0085 101	Sapporo
Japan	Ep0085 103	Sendai
Japan	Ep0085 144	Shinjuku-ku
Japan	Ep0085 104	Shizuoka
Japan	Ep0085 108	Suita
Japan	Ep0085 137	Suita
Japan	Ep0085 138	Tsukuba
Japan	Ep0085 133	Ushiku
Japan	Ep0085 109	Yamagata
Japan	Ep0085 120	Yokohama
Japan	Ep0085 150	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of study participants with treatment-emergent adverse events (TEAEs)	An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.	From study entry until Final Visit (up to 70 months)
Secondary	Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period	The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.	Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
Secondary	Responder rate in partial seizure frequency per 28 days over the Evaluation Period	The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.	Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period	A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.	During the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period	A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.	During the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period	A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.	During the Evaluation Period (up to 70 months)
Secondary	Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period	The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration.; Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants.	Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
Secondary	Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants	The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration.; A responder is defined as a study participant with a >= 50% reduction in seizure frequency from the Baseline Period.	Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period for directly enrolled study particpants	A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.	During the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period for directly enrolled study particpants	A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.	During the Evaluation Period (up to 70 months)
Secondary	Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants	A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.	During the Evaluation Period (up to 70 months)