A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Completed
CT.gov ID
NCT03083665
Collaborator
(none)
449
94
3
58.3
4.8
0.1

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
449 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
Actual Study Start Date :
Aug 22, 2017
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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:
  • Briviact
  • 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:
  • Briviact
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    1. 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

    2. 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.

    3. 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.

    4. 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).

    5. 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.

    6. 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.

    7. 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

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT03083665
    Other Study ID Numbers:
    • EP0083
    First Posted:
    Mar 20, 2017
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UCB Biopharma SRL
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022