Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03250377
Other study ID # EP0085
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A