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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy; Partial Seizures With or Without Secondary Generalization
• Intervention / Treatment: Drug: Brivaracetam

• Study Type: Interventional
• Enrollment (Anticipated): 217
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brivaracetam; Subjects randomized to this arm will receive open-label Brivaracetam	Drug: Brivaracetam; Pharmaceutical form: Film-coated tablet; Concentration: 25 mg and 50 mg; Route of administration: Oral use; Other Names: Briviact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2017
• Primary Completion (Anticipated): March 3, 2025
• Study Completion (Anticipated): March 3, 2025

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Epilepsy; Brivaracetam; Briviact; Partial seizures with or without secondary generalization
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neurologic Manifestations; Neoplastic Processes; Epilepsy; Neoplasm Metastasis; Seizures; Anticonvulsants; Brivaracetam
• Other Study ID Numbers: EP0085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No