A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Who is this study for? Patients 2 to 25 years of age with childhood absence epilepsy or juvenile absence epilepsy
What treatments are being studied? Brivaracetam
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 25
Healthy Volunteers: f
View:

• Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to \<4 years of age will be included in Stage 1

• Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria

• Study participants 2 to \<4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (GLUT1DS) genetic test

• Study participant is untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt

• Study participant has electroencephalogram (EEG) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), or on a historical EEG up to 12 weeks before enrollment

• Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment

• Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization

• Study participant has normal neurological examination, head size, development and cognition

• Body weight is ≥9 kg

• Male and female

• a) A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period b) A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: The study participant is premenarchial OR A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study treatment, corresponding to the time needed to eliminate study treatment

• Study participant provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Locations
United States
Alabama
N01269 115
RECRUITING
Birmingham
California
N01269 118
WITHDRAWN
Long Beach
N01269 105
RECRUITING
Orange
Colorado
N01269 116
COMPLETED
Denver
Florida
N01269 103
WITHDRAWN
Loxahatchee Groves
N01269 111
RECRUITING
Miami
N01269 101
COMPLETED
Tampa
N01269 104
COMPLETED
Winter Park
Georgia
N01269 110
COMPLETED
Augusta
North Carolina
N01269 109
RECRUITING
Winston-salem
New Jersey
N01269 100
RECRUITING
New Brunswick
Pennsylvania
N01269 106
COMPLETED
Philadelphia
Other Locations
Australia
N01269 203
WITHDRAWN
Heidelberg
N01269 202
WITHDRAWN
Melbourne
N01269 200
WITHDRAWN
Randwick
N01269 201
WITHDRAWN
South Brisbane
Belgium
N01269 301
WITHDRAWN
Brussels
N01269 300
WITHDRAWN
Edegem
Georgia
N01269 400
RECRUITING
Tbilisi
N01269 401
RECRUITING
Tbilisi
N01269 402
COMPLETED
Tbilisi
N01269 403
RECRUITING
Tbilisi
N01269 405
RECRUITING
Tbilisi
Italy
N01269 323
RECRUITING
Messina
N01269 321
RECRUITING
Milan
N01269 324
RECRUITING
Milan
N01269 320
RECRUITING
Pavia
N01269 322
RECRUITING
Roma
N01269 325
RECRUITING
Roma
N01269 326
RECRUITING
Verona
Poland
N01269 533
WITHDRAWN
Gdansk
N01269 530
WITHDRAWN
Krakow
N01269 534
WITHDRAWN
Lodz
N01269 531
WITHDRAWN
Lublin
N01269 532
WITHDRAWN
Warsaw
Romania
N01269 562
RECRUITING
Bucharest
N01269 563
RECRUITING
Bucharest
N01269 560
RECRUITING
Iași
N01269 561
RECRUITING
Timişoara, Judeţ Timiş
Slovakia
N01269 632
RECRUITING
Bardejov
N01269 630
RECRUITING
Dubnica Nad Váhom
N01269 631
COMPLETED
Nové Zámky
Spain
N01269 351
WITHDRAWN
Madrid
N01269 353
WITHDRAWN
Seville
N01269 354
RECRUITING
Terrassa
Ukraine
N01269 600
COMPLETED
Dnipro
N01269 601
COMPLETED
Dnipro
N01269 604
COMPLETED
Kharkiv
N01269 608
WITHDRAWN
Kharkiv
N01269 603
WITHDRAWN
Kyiv
N01269 606
WITHDRAWN
Kyiv
N01269 607
ACTIVE_NOT_RECRUITING
Uzhhorod
N01269 602
COMPLETED
Vinnytsia
Contact Information
Primary
UCB Cares
UCBCares@ucb.com
+1844599
Time Frame
Start Date: 2021-07-29
Estimated Completion Date: 2027-02-25
Participants
Target number of participants: 160
Treatments
Experimental: Brivaracetam 200 mg
Placebo-Controlled (PC) and Active Treatment (AT) Period:~Stage 1: Study participants randomized to brivaracetam (BRV) 200mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.
Experimental: Placebo to 200 mg brivaracetam
Placebo-Controlled (PC) and Active Treatment (AT) Period:~Stage 1: Study participants randomized to 'placebo to BRV 200mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 200mg/day (or equivalent dose) during the AT period.
Experimental: Brivaracetam 100 mg
Placebo-Controlled (PC) and Active Treatment (AT) Period:~Stage 1: Study participants randomized to BRV 100mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.
Experimental: Placebo to 100 mg brivaracetam
Placebo-Controlled (PC) and Active Treatment (AT) Period:~Stage 1: Study participants randomized to 'placebo to BRV 100mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 100mg/day (or equivalent dose) during the AT period.
Experimental: Optimal dose of BRV (defined following Stage 1)
Placebo-Controlled (PC) and Active Treatment Period (AT):~Stage 2: Study participants will be randomized in Stage 2 to receive a fixed dose of the optimal dose of brivaracetam (defined following Stage 1). Study participants randomized to the BRV optimal dose will receive this dose during the 2-week PC period and subsequent 11-week AT period.
Experimental: Placebo to BRV optimal dose (defined following Stage 1)
Placebo-Controlled (PC) and Active Treatment (AT) Period:~Stage 2: Study participants will be randomized in Stage 2 of the study to 'placebo to BRV optimal dose'. Study participants randomized to placebo to brivaracetam (BRV) optimal dose will receive placebo during the PC period followed by BRV optimal dose during the AT period.
Experimental: Brivaracetam received during RDW
Randomized Withdrawal (RDW) Period:~Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Participants who are randomized to this arm will continue on the Brivaracetam dose they were receiving in the AT period.
Experimental: Placebo received during RDW
Randomized Withdrawal (RDW) Period:~Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Study participants who are randomized to the placebo arm in the RDW Period will be tapered down to 0 mg and receive 0 mg for 2 weeks.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov

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