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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03083665
Other study ID # EP0083
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 22, 2017
Est. completion date June 30, 2022

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 efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.


Recruitment information / eligibility

Status Completed
Enrollment 449
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria: - Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive - Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method - Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period - Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1 - Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED Exclusion Criteria: - Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline - Subject is currently treated with levetiracetam - Subject has taken levetiracetam within 90 days prior to Visit 1

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Ep0083 905 Beijing
China Ep0083 906 Beijing
China Ep0083 907 Changchun
China Ep0083 901 Chengdu
China Ep0083 902 Guangzhou
China Ep0083 909 Guangzhou
China Ep0083 917 Guangzhou
China Ep0083 920 Guangzhou
China Ep0083 922 Guangzhou
China Ep0083 924 Guangzhou
China Ep0083 912 Hangzhou
China Ep0083 908 Lanzhou
China Ep0083 921 Nanchang
China Ep0083 926 Pingxiang
China Ep0083 910 Shijiazhuang
China Ep0083 925 Suzhou
China Ep0083 913 Wenzhou
China Ep0083 927 Xi'an
China Ep0083 930 Xinxiang
China Ep0083 916 Yinchuan
China Ep0083 918 Zhanjiang
China Ep0083 904 Zhengzhou
China Ep0083 923 Zunyi
Japan Ep0083 148 Adachi-ku
Japan Ep0083 116 Asaka
Japan Ep0083 126 Bunkyo-ku
Japan Ep0083 127 Bunkyo-ku
Japan Ep0083 146 Chiba-shi
Japan Ep0083 122 Hachinohe
Japan Ep0083 111 Hamamatsu
Japan Ep0083 141 Higashisonogi-gun Kawatana-cho
Japan Ep0083 110 Hiroshima
Japan Ep0083 121 Itami
Japan Ep0083 102 Kagoshima
Japan Ep0083 142 Kamakura
Japan Ep0083 140 Kawasaki
Japan Ep0083 123 Kodaira
Japan Ep0083 115 Kokubunji
Japan Ep0083 132 Koriyama
Japan Ep0083 112 Koshi
Japan Ep0083 128 Kurume
Japan Ep0083 124 Kyoto
Japan Ep0083 147 Kyoto
Japan Ep0083 105 Nagakute
Japan Ep0083 118 Nagoya
Japan Ep0083 136 Nagoya
Japan Ep0083 117 Nara
Japan Ep0083 129 Neyagawa
Japan Ep0083 106 Niigata
Japan Ep0083 130 Ôsaka
Japan Ep0083 131 Otsu
Japan Ep0083 114 Saitama
Japan Ep0083 101 Sapporo
Japan Ep0083 103 Sendai
Japan Ep0083 144 Shinjuku-ku
Japan Ep0083 104 Shizuoka
Japan Ep0083 108 Suita
Japan Ep0083 137 Suita
Japan Ep0083 138 Tsukuba
Japan Ep0083 133 Ushiku
Japan Ep0083 109 Yamagata
Japan Ep0083 120 Yokohama
Japan Ep0083 150 Yokohama
Malaysia Ep0083 207 Kota Bharu
Malaysia Ep0083 201 Kuala Lumpur
Malaysia Ep0083 206 Kuala Terengganu
Malaysia Ep0083 204 Kuching
Malaysia Ep0083 209 Miri
Malaysia Ep0083 202 Perai
Malaysia Ep0083 208 Pulau Pinang
Malaysia Ep0083 203 Sungai Buloh
Philippines Ep0083 303 Cebu City
Philippines Ep0083 304 Cebu City
Philippines Ep0083 306 Davao City
Philippines Ep0083 307 Iloilo City
Philippines Ep0083 301 Manila
Philippines Ep0083 302 Manila
Philippines Ep0083 310 Manila
Philippines Ep0083 309 Quezon City
Singapore Ep0083 401 Singapore
Singapore Ep0083 402 Singapore
Taiwan Ep0083 502 Chiayi City
Taiwan Ep0083 505 Kaohsiung
Taiwan Ep0083 503 Taichung
Taiwan Ep0083 504 Taichung City
Taiwan Ep0083 501 Tainan
Thailand Ep0083 602 Bangkok
Thailand Ep0083 605 Bangkok
Thailand Ep0083 606 Bangkok
Thailand Ep0083 607 Bangkok
Thailand Ep0083 609 Bangkok
Thailand Ep0083 601 Khon Kaen
Thailand Ep0083 603 Muang
Thailand Ep0083 608 Muang

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

China,  Japan,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Primary Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Primary Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) Serious Adverse event (SAE) was defined as any events which: • results in death, • is life-threatening threatening (note that this did not include a reaction that might have caused death had it occurred in a more severe form.), •results in significant or persistent disability/incapacity, • results in a congenital anomaly/birth defect (including that occurring in a fetus), • results in Important medical event that, based upon appropriate medical judgment, may jeopardize the participant and might require medical or surgical intervention to prevent 1 of the other outcomes listed here, and • results in initial inpatient hospitalization or prolongation of hospitalization. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period. From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Primary Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period According to International League Against Epilepsy (ILAE) classification (1981), seizures were classified as type IA (IA1, IA2, IA3, and IA4), IB, IC, II (IIA, IIB, IIC, IID, IIE, and IIF) or III. 28 day adjusted seizure frequency for partial seizures (seizure types IA+IB+IC) was calculated for treatment period by dividing the number of partial seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28. From Baseline to 12-week Treatment Period
Secondary 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period Responders were those participants with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days. 50% Responder rate was calculated for treatment period by dividing the number of 50% responders by the number of participants in the analysis set and multiplying the resulting value by 100. From Baseline to 12-week Treatment Period
Secondary Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency, and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period. From Baseline to 12-week Treatment Period
Secondary Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period The percentage of participants within each of the following categories of percent change in partial seizure frequency from Baseline to the Treatment Period were summarized for each treatment group: 100%, 75% to less than 100%, 50% to less than 75%, 25% to less than 50%, -25% to less than 25%, and less than -25%. Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. From Baseline to 12-week Treatment Period
Secondary All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period There were three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III). 28 day adjusted seizure frequency for all seizure types was calculated for treatment period by dividing the number of targeted seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28. During the 12-week Treatment Period
Secondary Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period Participants were defined as seizure free, if they did not have missing diary days and no reported seizures during the Treatment Period. During the 12-week Treatment Period
Secondary Time to 1st Partial Seizure During the 12-week Treatment Period The evaluation of time to 1st partial seizure was based on the relative day of occurrence of the 1st partial seizure during the Treatment Period. During the 12-week Treatment Period
Secondary Time to 5th Partial Seizure During the 12-week Treatment Period The evaluation of time to 5th partial seizure was based on the relative day of occurrence of the 5th partial seizure during the Treatment Period. During the 12-week Treatment Period
Secondary Time to 10th Partial Seizure During the 12-week Treatment Period The evaluation of time to 10th partial seizure was based on the relative day of occurrence of the 10th partial seizure during the Treatment Period. During the 12-week Treatment Period
Secondary Brivaracetam Plasma Concentration Blood samples were collected at indicated time points for the 50mg/day and 200mg/day groups to determine the brivaracetam plasma concentration. Participants of arm 'BRV 200 mg/day' received BRV 200 mg/day until Week 12 only and 150 mg/day during the Transition Period at Week 14. Therefore, the data is reported according to the dosage information at specified time point. As per planned analysis, one blood sample was collected for BRV plasma levels during each dosing interval between 0 to 4 hours, 4 to 8 hours, and 8 to 12 hours postdose. Plasma samples were collected at >0-4hours, >4-8hours, >8hours in weeks 2, 4, 8, 12, and 14
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