Clinical trial NCT03370120: Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Official title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Drug-Resistant Epilepsy
Focal-Onset Seizures
Keywords: Drug-Resistant Epilepsy
Padsevonil
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.


Eligibility criteria: Inclusion Criteria:

* Subject is an adult (18 years of age or more )
* Subject with epilepsy who has completed 1 of the previous Padsevonil (PSL) studies which allow access to the present study
* Female subjects of child bearing potential must have a serum negative pregnancy test at the Entry Visit, which is confirmed to be negative by urine testing prior to further dispensing at each study visit thereafter. Subjects will be withdrawn from the study as soon as pregnancy is known. Female subjects will use an efficient form of contraception for the duration of the study and for a period of 3 months after their final dose of PSL.

Exclusion Criteria:

* Subject has any severe medical, neurological, or psychiatric condition, or laboratory value which may have an impact on the safety of the subject
* Subject has active suicidal ideation as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Since Last Visit' version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has \>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (\>= l.5x ULN total bilirubin if known Gilbert's syndrome) at the Entry Visit
* Subject has a clinically-significant abnormality on electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Subject has an abnormality on echocardiogram at last echocardiogram assessment, or foreseen in parent study as assessed by central reader that is accompanied by clinical symptoms or a Grade 2\* (or higher)/moderate severity abnormality, or a history of rheumatic heart disease, or other known valvular abnormalities (\*according to the ASE Guidelines, 2017; Zoghbi et al 2017)
* Female subject who plans to be pregnant or is breastfeeding

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Participant and/or Caregiver or Observed by the Investigator During the Entire Study
timeFrame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
timeFrame: From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
measure: Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period
timeFrame: From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ep0093 839
state: Arizona
city: La Jolla
country: United States
facility: Ep0093 815
state: California
city: San Francisco
country: United States
facility: Ep0093 801
state: California
city: Honolulu
country: United States
facility: Ep0093 803
state: Hawaii
city: Fort Wayne
country: United States
facility: Ep0093 638
state: Indiana
city: Lexington
country: United States
facility: Ep0093 707
state: Kentucky
city: Baltimore
country: United States
facility: Ep0093 822
state: Maryland
city: Bethesda
country: United States
facility: Ep0093 818
state: Maryland
city: Boston
country: United States
facility: Ep0093 889
state: Massachusetts
city: Golden Valley
country: United States
facility: Ep0093 645
state: Minnesota
city: Saint Paul
country: United States
facility: Ep0093 817
state: Minnesota
city: Hackensack
country: United States
facility: Ep0093 806
state: New Jersey
city: Bronx
country: United States
facility: Ep0093 895
state: New York
city: Syracuse
country: United States
facility: Ep0093 893
state: New York
city: Chapel Hill
country: United States
facility: Ep0093 890
state: North Carolina
city: Charlotte
country: United States
facility: Ep0093 884
state: North Carolina
city: Columbia
country: United States
facility: Ep0093 642
state: Ohio
city: Philadelphia
country: United States
facility: Ep0093 802
state: Pennsylvania
city: Cordova
country: United States
facility: Ep0093 838
state: Tennessee
city: Nashville
country: United States
facility: Ep0093 835
state: Tennessee
city: Austin
country: United States
facility: Ep0093 805
state: Texas
city: Austin
country: United States
facility: Ep0093 844
state: Texas
city: Round Rock
country: United States
facility: Ep0093 824
state: Texas
city: San Antonio
country: United States
facility: Ep0093 870
state: Texas
city: Renton
country: United States
facility: Ep0093 639
state: Washington
city: Box Hill
country: Australia
facility: Ep0093 855
city: Clayton
country: Australia
facility: Ep0093 857
city: Fitzroy
country: Australia
facility: Ep0093 850
city: Heidelberg
country: Australia
facility: Ep0093 853
city: Herston
country: Australia
facility: Ep0093 859
city: Melbourne
country: Australia
facility: Ep0093 852
city: Randwick
country: Australia
facility: Ep0093 856
city: Westmead
country: Australia
facility: Ep0093 854
city: Brugge
country: Belgium
facility: Ep0093 102
city: Brussels
country: Belgium
facility: Ep0093 101
city: Gent
country: Belgium
facility: Ep0093 105
city: Leuven
country: Belgium
facility: Ep0093 100
city: Ottignies
country: Belgium
facility: Ep0093 107
city: Sarajevo
country: Bosnia and Herzegovina
facility: Ep0093 075
city: Tuzla
country: Bosnia and Herzegovina
facility: Ep0093 082
city: Blagoevgrad
country: Bulgaria
facility: Ep0093 150
city: Pleven
country: Bulgaria
facility: Ep0093 151
city: Pleven
country: Bulgaria
facility: Ep0093 153
city: Pleven
country: Bulgaria
facility: Ep0093 156
city: Sofia
country: Bulgaria
facility: Ep0093 152
city: Sofia
country: Bulgaria
facility: Ep0093 154
city: Sofia
country: Bulgaria
facility: Ep0093 155
city: Greenfield Park
country: Canada
facility: Ep0093 200
city: London
country: Canada
facility: Ep0093 205
city: Montréal
country: Canada
facility: Ep0093 201
city: Zagreb
country: Croatia
facility: Ep0093 125
city: Brno
country: Czechia
facility: Ep0093 254
city: Ostrava
country: Czechia
facility: Ep0093 255
city: Praha 6
country: Czechia
facility: Ep0093 251
city: Praha
country: Czechia
facility: Ep0093 250
city: Praha
country: Czechia
facility: Ep0093 253
city: Aarhus
country: Denmark
facility: Ep0093 016
city: Odense
country: Denmark
facility: Ep0093 015
city: Tallinn
country: Estonia
facility: Ep0093 277
city: Tallin
country: Estonia
facility: Ep0093 276
city: Tartu
country: Estonia
facility: Ep0093 275
city: Tampere
country: Finland
facility: Ep0093 027
city: Clermont-Ferrand
country: France
facility: Ep0093 307
city: Dijon
country: France
facility: Ep0093 309
city: Lille
country: France
facility: Ep0093 300
city: Montpellier
country: France
facility: Ep0093 302
city: Rennes
country: France
facility: Ep0093 303
city: Strasbourg
country: France
facility: Ep0093 301
city: Berlin
country: Germany
facility: Ep0093 365
city: Bernau
country: Germany
facility: Ep0093 362
city: Bielefeld
country: Germany
facility: Ep0093 363
city: Bonn
country: Germany
facility: Ep0093 358
city: Frankfurt
country: Germany
facility: Ep0093 350
city: Freiburg
country: Germany
facility: Ep0093 360
city: Jena
country: Germany
facility: Ep0093 368
city: Kehl
country: Germany
facility: Ep0093 366
city: Leipzig
country: Germany
facility: Ep0093 357
city: Marburg
country: Germany
facility: Ep0093 353
city: München
country: Germany
facility: Ep0093 354
city: Münster
country: Germany
facility: Ep0093 351
city: Osnabrück
country: Germany
facility: Ep0093 356
city: Tübingen
country: Germany
facility: Ep0093 352
city: Thessaloníki
country: Greece
facility: Ep0093 426
city: Thessaloníki
country: Greece
facility: Ep0093 427
city: Budapest
country: Hungary
facility: Ep0093 400
city: Budapest
country: Hungary
facility: Ep0093 403
city: Debrecen
country: Hungary
facility: Ep0093 402
city: Cork
country: Ireland
facility: Ep0093 035
city: Bologna
country: Italy
facility: Ep0093 462
city: Cagliari
country: Italy
facility: Ep0093 450
city: Foggia
country: Italy
facility: Ep0093 451
city: Foggia
country: Italy
facility: Ep0093 461
city: Milano
country: Italy
facility: Ep0093 452
city: Pavia
country: Italy
facility: Ep0093 459
city: Pozzilli
country: Italy
facility: Ep0093 458
city: Roma
country: Italy
facility: Ep0093 455
city: Roma
country: Italy
facility: Ep0093 457
city: Roma
country: Italy
facility: Ep0093 460
city: Asahikawa
country: Japan
facility: Ep0093 526
city: Asaka
country: Japan
facility: Ep0093 501
city: Bunkyō-Ku
country: Japan
facility: Ep0093 521
city: Fukuoka
country: Japan
facility: Ep0093 511
city: Hamamatsu
country: Japan
facility: Ep0093 504
city: Hiroshima
country: Japan
facility: Ep0093 505
city: Hōfu
country: Japan
facility: Ep0093 513
city: Itami
country: Japan
facility: Ep0093 507
city: Kyoto
country: Japan
facility: Ep0093 514
city: Nagakute
country: Japan
facility: Ep0093 512
city: Niigata
country: Japan
facility: Ep0093 510
city: Saitama
country: Japan
facility: Ep0093 515
city: Shizuoka
country: Japan
facility: Ep0093 509
city: Yonago
country: Japan
facility: Ep0093 529
city: Kaunas
country: Lithuania
facility: Ep0093 703
city: Vilnius
country: Lithuania
facility: Ep0093 702
city: Culiacán
country: Mexico
facility: Ep0093 553
city: Mexico
country: Mexico
facility: Ep0093 552
city: Gdańsk
country: Poland
facility: Ep0093 601
city: Grodzisk Mazowiecki
country: Poland
facility: Ep0093 607
city: Katowice
country: Poland
facility: Ep0093 605
city: Katowice
country: Poland
facility: Ep0093 616
city: Kraków
country: Poland
facility: Ep0093 603
city: Kraków
country: Poland
facility: Ep0093 614
city: Lublin
country: Poland
facility: Ep0093 604
city: Lublin
country: Poland
facility: Ep0093 610
city: Nowa Sól
country: Poland
facility: Ep0093 606
city: Poznań
country: Poland
facility: Ep0093 600
city: Poznań
country: Poland
facility: Ep0093 609
city: Świdnik
country: Poland
facility: Ep0093 602
city: Bucuresti
country: Romania
facility: Ep0093 926
city: Belgrade
country: Serbia
facility: Ep0093 327
city: Bardejov
country: Slovakia
facility: Ep0093 004
city: Alicante
country: Spain
facility: Ep0093 662
city: Barakaldo
country: Spain
facility: Ep0093 668
city: Barcelona
country: Spain
facility: Ep0093 651
city: Barcelona
country: Spain
facility: Ep0093 652
city: Barcelona
country: Spain
facility: Ep0093 664
city: Córdoba
country: Spain
facility: Ep0093 666
city: Hospitalet de Llobregat
country: Spain
facility: Ep0093 658
city: Madrid
country: Spain
facility: Ep0093 656
city: Madrid
country: Spain
facility: Ep0093 660
city: Madrid
country: Spain
facility: Ep0093 667
city: Madrid
country: Spain
facility: Ep0093 674
city: Málaga
country: Spain
facility: Ep0093 659
city: Terrassa
country: Spain
facility: Ep0093 665
city: Valencia
country: Spain
facility: Ep0093 657
city: Valladolid
country: Spain
facility: Ep0093 653
city: Istanbul
country: Turkey
facility: Ep0093 900
city: Istanbul
country: Turkey
facility: Ep0093 901
city: Istanbul
country: Turkey
facility: Ep0093 904
city: Istanbul
country: Turkey
facility: Ep0093 906
city: Istanbul
country: Turkey
facility: Ep0093 909
city: Birmingham
country: United Kingdom
facility: Ep0093 752
city: Brighton
country: United Kingdom
facility: Ep0093 766
city: Swansea
country: United Kingdom
facility: Ep0093 751
city: Swansea
country: United Kingdom
facility: Ep0093 753
city: Swansea
country: United Kingdom
facility: Ep0093 764
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: