A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Placebo 12 weeks Treatment Period: Subjects will receive Placebo 4 weeks Down-Titration Period: Subjects will receive Placebo |
Drug: Placebo
Pharmaceutical form: Film-coated tablets
Route of administration: Oral use
|
Experimental: BRV 50 mg/day 12 weeks Treatment Period: Subjects will receive BRV 50 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period |
Drug: Placebo
Pharmaceutical form: Film-coated tablets
Route of administration: Oral use
Drug: Brivaracetam
Pharmaceutical form: Film-coated tablets
Concentration: 25 mg tablets and 50 mg tablets
Route of administration: Oral use
Other Names:
|
Experimental: BRV 200 mg/day 12 weeks Treatment Period: Subjects will receive BRV 200 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period |
Drug: Placebo
Pharmaceutical form: Film-coated tablets
Route of administration: Oral use
Drug: Brivaracetam
Pharmaceutical form: Film-coated tablets
Concentration: 25 mg tablets and 50 mg tablets
Route of administration: Oral use
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) [From Screening (Week -8) until Safety Visit (up to Week 18)]
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.
- Partial seizure frequency per 28 days during the 12-week Treatment Period [From Baseline to 12-weeks Treatement Period]
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
- Percent change in partial seizure frequency during the 12-week Treatment Period [From Baseline to 12-weeks Tratement Period]
Calculated as (seizure frequency Baseline - seizure frequency Treatment) *100/ (seizure frequency Baseline). The higher the values for percent change in partial seizure (PS) frequency, the higher the improvement from Baseline.
Secondary Outcome Measures
- 50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [From Baseline to 12-week Treatment Period]
Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days
- Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [From Baseline to 12-week Treatment Period]
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.
- Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period [From Baseline to 12-week Treatment Period]
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.
- All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period [During the 12-week Treatment Period]
There are three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III).
- Percentage of subjects who are seizure free (partial, all epileptic seizures) during the 12-week Treatment Period [During the 12-week Treatment Period]
A subject was considered seizure free, if no seizure was reported during the 12-week Treatment Period.
- Time to nth (n= 1, 5, 10) partial seizure during the 12-week Treatment Period [During the 12-week Treatment Period]
Number of days to first, fifth, and tenth seizure after baseline.
- Brivaracetam plasma concentration [Plasma samples will be collected in week 2, 4, 8, 12, 14.]
Blood samples will be collected at indicated time points to determine the brivaracetam plasma concentration.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
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Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
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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
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Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
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Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug AED. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
Exclusion Criteria:
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Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
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Subject is currently treated with levetiracetam
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Subject has taken levetiracetam within 90 days prior to Visit 1
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ep0083 905 | Beijing | China | ||
2 | Ep0083 906 | Beijing | China | ||
3 | Ep0083 907 | Changchun | China | ||
4 | Ep0083 901 | Chengdu | China | ||
5 | Ep0083 902 | Guangzhou | China | ||
6 | Ep0083 909 | Guangzhou | China | ||
7 | Ep0083 917 | Guangzhou | China | ||
8 | Ep0083 920 | Guangzhou | China | ||
9 | Ep0083 922 | Guangzhou | China | ||
10 | Ep0083 924 | Guangzhou | China | ||
11 | Ep0083 912 | Hangzhou | China | ||
12 | Ep0083 908 | Lanzhou | China | ||
13 | Ep0083 921 | Nanchang | China | ||
14 | Ep0083 926 | Pingxiang | China | ||
15 | Ep0083 910 | Shijiazhuang | China | ||
16 | Ep0083 925 | Suzhou | China | ||
17 | Ep0083 913 | Wenzhou | China | ||
18 | Ep0083 927 | Xi'an | China | ||
19 | Ep0083 930 | Xinxiang | China | ||
20 | Ep0083 916 | Yinchuan | China | ||
21 | Ep0083 918 | Zhanjiang | China | ||
22 | Ep0083 904 | Zhengzhou | China | ||
23 | Ep0083 923 | Zunyi | China | ||
24 | Ep0083 148 | Adachi-ku | Japan | ||
25 | Ep0083 116 | Asaka | Japan | ||
26 | Ep0083 126 | Bunkyo-ku | Japan | ||
27 | Ep0083 127 | Bunkyo-ku | Japan | ||
28 | Ep0083 146 | Chiba-shi | Japan | ||
29 | Ep0083 122 | Hachinohe | Japan | ||
30 | Ep0083 111 | Hamamatsu | Japan | ||
31 | Ep0083 141 | Higashisonogi-gun Kawatana-cho | Japan | ||
32 | Ep0083 110 | Hiroshima | Japan | ||
33 | Ep0083 121 | Itami | Japan | ||
34 | Ep0083 102 | Kagoshima | Japan | ||
35 | Ep0083 142 | Kamakura | Japan | ||
36 | Ep0083 140 | Kawasaki | Japan | ||
37 | Ep0083 123 | Kodaira | Japan | ||
38 | Ep0083 115 | Kokubunji | Japan | ||
39 | Ep0083 132 | Koriyama | Japan | ||
40 | Ep0083 112 | Koshi | Japan | ||
41 | Ep0083 128 | Kurume | Japan | ||
42 | Ep0083 124 | Kyoto | Japan | ||
43 | Ep0083 147 | Kyoto | Japan | ||
44 | Ep0083 105 | Nagakute | Japan | ||
45 | Ep0083 118 | Nagoya | Japan | ||
46 | Ep0083 136 | Nagoya | Japan | ||
47 | Ep0083 117 | Nara | Japan | ||
48 | Ep0083 129 | Neyagawa | Japan | ||
49 | Ep0083 106 | Niigata | Japan | ||
50 | Ep0083 114 | Saitama | Japan | ||
51 | Ep0083 101 | Sapporo | Japan | ||
52 | Ep0083 103 | Sendai | Japan | ||
53 | Ep0083 144 | Shinjuku-ku | Japan | ||
54 | Ep0083 104 | Shizuoka | Japan | ||
55 | Ep0083 108 | Suita | Japan | ||
56 | Ep0083 137 | Suita | Japan | ||
57 | Ep0083 138 | Tsukuba | Japan | ||
58 | Ep0083 133 | Ushiku | Japan | ||
59 | Ep0083 109 | Yamagata | Japan | ||
60 | Ep0083 120 | Yokohama | Japan | ||
61 | Ep0083 150 | Yokohama | Japan | ||
62 | Ep0083 130 | Ôsaka | Japan | ||
63 | Ep0083 131 | Ōtsu | Japan | ||
64 | Ep0083 207 | Kota Bharu | Malaysia | ||
65 | Ep0083 201 | Kuala Lumpur | Malaysia | ||
66 | Ep0083 206 | Kuala Terengganu | Malaysia | ||
67 | Ep0083 204 | Kuching | Malaysia | ||
68 | Ep0083 209 | Miri | Malaysia | ||
69 | Ep0083 202 | Perai | Malaysia | ||
70 | Ep0083 208 | Pulau Pinang | Malaysia | ||
71 | Ep0083 203 | Sungai Buloh | Malaysia | ||
72 | Ep0083 303 | Cebu City | Philippines | ||
73 | Ep0083 304 | Cebu City | Philippines | ||
74 | Ep0083 306 | Davao City | Philippines | ||
75 | Ep0083 307 | Iloilo City | Philippines | ||
76 | Ep0083 301 | Manila | Philippines | ||
77 | Ep0083 302 | Manila | Philippines | ||
78 | Ep0083 310 | Manila | Philippines | ||
79 | Ep0083 309 | Quezon City | Philippines | ||
80 | Ep0083 401 | Singapore | Singapore | ||
81 | Ep0083 402 | Singapore | Singapore | ||
82 | Ep0083 502 | Chiayi City | Taiwan | ||
83 | Ep0083 505 | Kaohsiung | Taiwan | ||
84 | Ep0083 504 | Taichung City | Taiwan | ||
85 | Ep0083 503 | Taichung | Taiwan | ||
86 | Ep0083 501 | Tainan | Taiwan | ||
87 | Ep0083 602 | Bangkok | Thailand | ||
88 | Ep0083 605 | Bangkok | Thailand | ||
89 | Ep0083 606 | Bangkok | Thailand | ||
90 | Ep0083 607 | Bangkok | Thailand | ||
91 | Ep0083 609 | Bangkok | Thailand | ||
92 | Ep0083 601 | Khon Kaen | Thailand | ||
93 | Ep0083 603 | Muang | Thailand | ||
94 | Ep0083 608 | Muang | Thailand |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EP0083