Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
NCT ID: NCT03370120
Last Updated: 2021-12-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
406 participants
INTERVENTIONAL
2018-08-27
2020-12-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Padsevonil
Padsevonil will be administered in an open-label manner. The individual starting dose of each subject will be the one at the end of the parent study.
Once subjects enter EP0093 further individual dose adjustments are allowed after 1 week to the extent possible with the combination of tablet strengths available.
Padsevonil
* Pharmaceutical Form: film-coated tablet
* Route of Administration: Oral use
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Padsevonil
* Pharmaceutical Form: film-coated tablet
* Route of Administration: Oral use
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma SRL
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ep0093 839
Chandler, Arizona, United States
Ep0093 815
La Jolla, California, United States
Ep0093 801
San Francisco, California, United States
Ep0093 803
Honolulu, Hawaii, United States
Ep0093 638
Fort Wayne, Indiana, United States
Ep0093 707
Lexington, Kentucky, United States
Ep0093 822
Baltimore, Maryland, United States
Ep0093 818
Bethesda, Maryland, United States
Ep0093 889
Boston, Massachusetts, United States
Ep0093 645
Golden Valley, Minnesota, United States
Ep0093 817
Saint Paul, Minnesota, United States
Ep0093 806
Hackensack, New Jersey, United States
Ep0093 893
Syracuse, New York, United States
Ep0093 895
The Bronx, New York, United States
Ep0093 890
Chapel Hill, North Carolina, United States
Ep0093 884
Charlotte, North Carolina, United States
Ep0093 642
Columbia, Ohio, United States
Ep0093 802
Philadelphia, Pennsylvania, United States
Ep0093 838
Cordova, Tennessee, United States
Ep0093 835
Nashville, Tennessee, United States
Ep0093 805
Austin, Texas, United States
Ep0093 844
Austin, Texas, United States
Ep0093 824
Round Rock, Texas, United States
Ep0093 870
San Antonio, Texas, United States
Ep0093 639
Renton, Washington, United States
Ep0093 855
Box Hill, , Australia
Ep0093 857
Clayton, , Australia
Ep0093 850
Fitzroy, , Australia
Ep0093 853
Heidelberg, , Australia
Ep0093 859
Herston, , Australia
Ep0093 852
Melbourne, , Australia
Ep0093 856
Randwick, , Australia
Ep0093 854
Westmead, , Australia
Ep0093 102
Bruges, , Belgium
Ep0093 101
Brussels, , Belgium
Ep0093 105
Ghent, , Belgium
Ep0093 100
Leuven, , Belgium
Ep0093 107
Ottignies, , Belgium
Ep0093 075
Sarajevo, , Bosnia and Herzegovina
Ep0093 082
Tuzla, , Bosnia and Herzegovina
Ep0093 150
Blagoevgrad, , Bulgaria
Ep0093 151
Pleven, , Bulgaria
Ep0093 153
Pleven, , Bulgaria
Ep0093 156
Pleven, , Bulgaria
Ep0093 152
Sofia, , Bulgaria
Ep0093 154
Sofia, , Bulgaria
Ep0093 155
Sofia, , Bulgaria
Ep0093 200
Greenfield Park, , Canada
Ep0093 205
London, , Canada
Ep0093 201
Montreal, , Canada
Ep0093 125
Zagreb, , Croatia
Ep0093 254
Brno, , Czechia
Ep0093 255
Ostrava, , Czechia
Ep0093 250
Prague, , Czechia
Ep0093 251
Prague, , Czechia
Ep0093 253
Prague, , Czechia
Ep0093 016
Aarhus, , Denmark
Ep0093 015
Odense, , Denmark
Ep0093 276
Tallinn, , Estonia
Ep0093 277
Tallinn, , Estonia
Ep0093 275
Tartu, , Estonia
Ep0093 027
Tampere, , Finland
Ep0093 307
Clermont-Ferrand, , France
Ep0093 309
Dijon, , France
Ep0093 300
Lille, , France
Ep0093 302
Montpellier, , France
Ep0093 303
Rennes, , France
Ep0093 301
Strasbourg, , France
Ep0093 365
Berlin, , Germany
Ep0093 362
Bernau, , Germany
Ep0093 363
Bielefeld, , Germany
Ep0093 358
Bonn, , Germany
Ep0093 350
Frankfurt, , Germany
Ep0093 360
Freiburg im Breisgau, , Germany
Ep0093 368
Jena, , Germany
Ep0093 366
Kehl, , Germany
Ep0093 357
Leipzig, , Germany
Ep0093 353
Marburg, , Germany
Ep0093 354
München, , Germany
Ep0093 351
Münster, , Germany
Ep0093 356
Osnabrück, , Germany
Ep0093 352
Tübingen, , Germany
Ep0093 426
Thessaloniki, , Greece
Ep0093 427
Thessaloniki, , Greece
Ep0093 400
Budapest, , Hungary
Ep0093 403
Budapest, , Hungary
Ep0093 402
Debrecen, , Hungary
Ep0093 035
Cork, , Ireland
Ep0093 462
Bologna, , Italy
Ep0093 450
Cagliari, , Italy
Ep0093 451
Foggia, , Italy
Ep0093 461
Foggia, , Italy
Ep0093 452
Milan, , Italy
Ep0093 459
Pavia, , Italy
Ep0093 458
Pozzilli, , Italy
Ep0093 455
Roma, , Italy
Ep0093 457
Roma, , Italy
Ep0093 460
Roma, , Italy
Ep0093 526
Asahikawa, , Japan
Ep0093 501
Asaka, , Japan
Ep0093 521
Bunkyō City, , Japan
Ep0093 511
Fukuoka, , Japan
Ep0093 504
Hamamatsu, , Japan
Ep0093 505
Hiroshima, , Japan
Ep0093 513
Hōfu, , Japan
Ep0093 507
Itami, , Japan
Ep0093 514
Kyoto, , Japan
Ep0093 512
Nagakute, , Japan
Ep0093 510
Niigata, , Japan
Ep0093 515
Saitama, , Japan
Ep0093 509
Shizuoka, , Japan
Ep0093 529
Yonago, , Japan
Ep0093 703
Kaunas, , Lithuania
Ep0093 702
Vilnius, , Lithuania
Ep0093 553
Culiacán, , Mexico
Ep0093 552
México, , Mexico
Ep0093 601
Gdansk, , Poland
Ep0093 607
Grodzisk Mazowiecki, , Poland
Ep0093 605
Katowice, , Poland
Ep0093 616
Katowice, , Poland
Ep0093 603
Krakow, , Poland
Ep0093 614
Krakow, , Poland
Ep0093 604
Lublin, , Poland
Ep0093 610
Lublin, , Poland
Ep0093 606
Nowa Sól, , Poland
Ep0093 600
Poznan, , Poland
Ep0093 609
Poznan, , Poland
Ep0093 602
Świdnik, , Poland
Ep0093 926
Bucharest, , Romania
Ep0093 327
Belgrade, , Serbia
Ep0093 004
Bardejov, , Slovakia
Ep0093 662
Alicante, , Spain
Ep0093 668
Barakaldo, , Spain
Ep0093 651
Barcelona, , Spain
Ep0093 652
Barcelona, , Spain
Ep0093 664
Barcelona, , Spain
Ep0093 666
Córdoba, , Spain
Ep0093 658
L'Hospitalet de Llobregat, , Spain
Ep0093 656
Madrid, , Spain
Ep0093 660
Madrid, , Spain
Ep0093 667
Madrid, , Spain
Ep0093 674
Madrid, , Spain
Ep0093 659
Málaga, , Spain
Ep0093 665
Terrassa, , Spain
Ep0093 657
Valencia, , Spain
Ep0093 653
Valladolid, , Spain
Ep0093 900
Istanbul, , Turkey (Türkiye)
Ep0093 901
Istanbul, , Turkey (Türkiye)
Ep0093 904
Istanbul, , Turkey (Türkiye)
Ep0093 906
Istanbul, , Turkey (Türkiye)
Ep0093 909
Istanbul, , Turkey (Türkiye)
Ep0093 752
Birmingham, , United Kingdom
Ep0093 766
Brighton, , United Kingdom
Ep0093 751
Swansea, , United Kingdom
Ep0093 753
Swansea, , United Kingdom
Ep0093 764
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003241-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP0093
Identifier Type: -
Identifier Source: org_study_id