Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
- Registration Number
- NCT03370120
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 406
- 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 Subjects will be withdrawn from the study as soon as pregnancy is known.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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Padsevonil 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.
- Primary Outcome Measures
Name Time Method 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 From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years) An Adverse Event is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event that was not present prior to the initiation of the first dose of study treatment in this study or any unresolved event already present before initiation of the first dose that worsens in intensity following exposure to the treatment.
Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study Seizure frequency refers to 28-day adjusted frequency. Observable focal-onset seizures refer to Type IAl, IB, and IC (according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981). Focal-onset seizures include all Type I seizures.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (156)
Ep0093 645
🇺🇸Golden Valley, Minnesota, United States
Ep0093 806
🇺🇸Hackensack, New Jersey, United States
Ep0093 802
🇺🇸Philadelphia, Pennsylvania, United States
Ep0093 884
🇺🇸Charlotte, North Carolina, United States
Ep0093 857
🇦🇺Clayton, Australia
Ep0093 859
🇦🇺Herston, Australia
Ep0093 152
🇧🇬Sofia, Bulgaria
Ep0093 201
🇨🇦Montréal, Canada
Ep0093 363
🇩🇪Bielefeld, Germany
Ep0093 616
🇵🇱Katowice, Poland
Ep0093 657
🇪🇸Valencia, Spain
Ep0093 600
🇵🇱Poznań, Poland
Ep0093 609
🇵🇱Poznań, Poland
Ep0093 602
🇵🇱Świdnik, Poland
Ep0093 926
🇷🇴Bucuresti, Romania
Ep0093 327
🇷🇸Belgrade, Serbia
Ep0093 658
🇪🇸Hospitalet de Llobregat, Spain
Ep0093 656
🇪🇸Madrid, Spain
Ep0093 753
🇬🇧Swansea, United Kingdom
Ep0093 889
🇺🇸Boston, Massachusetts, United States
Ep0093 105
🇧🇪Gent, Belgium
Ep0093 838
🇺🇸Cordova, Tennessee, United States
Ep0093 277
🇪🇪Tallinn, Estonia
Ep0093 101
🇧🇪Brussels, Belgium
Ep0093 107
🇧🇪Ottignies, Belgium
Ep0093 510
🇯🇵Niigata, Japan
Ep0093 156
🇧🇬Pleven, Bulgaria
Ep0093 125
🇭🇷Zagreb, Croatia
Ep0093 276
🇪🇪Tallin, Estonia
Ep0093 027
🇫🇮Tampere, Finland
Ep0093 839
🇺🇸Chandler, Arizona, United States
Ep0093 638
🇺🇸Fort Wayne, Indiana, United States
Ep0093 822
🇺🇸Baltimore, Maryland, United States
Ep0093 707
🇺🇸Lexington, Kentucky, United States
Ep0093 856
🇦🇺Randwick, Australia
Ep0093 817
🇺🇸Saint Paul, Minnesota, United States
Ep0093 639
🇺🇸Renton, Washington, United States
Ep0093 855
🇦🇺Box Hill, Australia
Ep0093 895
🇺🇸Bronx, New York, United States
Ep0093 893
🇺🇸Syracuse, New York, United States
Ep0093 824
🇺🇸Round Rock, Texas, United States
Ep0093 642
🇺🇸Columbia, Ohio, United States
Ep0093 850
🇦🇺Fitzroy, Australia
Ep0093 853
🇦🇺Heidelberg, Australia
Ep0093 102
🇧🇪Brugge, Belgium
Ep0093 854
🇦🇺Westmead, Australia
Ep0093 100
🇧🇪Leuven, Belgium
Ep0093 153
🇧🇬Pleven, Bulgaria
Ep0093 200
🇨🇦Greenfield Park, Canada
Ep0093 205
🇨🇦London, Canada
Ep0093 075
🇧🇦Sarajevo, Bosnia and Herzegovina
Ep0093 082
🇧🇦Tuzla, Bosnia and Herzegovina
Ep0093 015
🇩🇰Odense, Denmark
Ep0093 150
🇧🇬Blagoevgrad, Bulgaria
Ep0093 254
🇨🇿Brno, Czechia
Ep0093 154
🇧🇬Sofia, Bulgaria
Ep0093 155
🇧🇬Sofia, Bulgaria
Ep0093 255
🇨🇿Ostrava, Czechia
Ep0093 151
🇧🇬Pleven, Bulgaria
Ep0093 016
🇩🇰Aarhus, Denmark
Ep0093 250
🇨🇿Praha, Czechia
Ep0093 300
🇫🇷Lille, France
Ep0093 303
🇫🇷Rennes, France
Ep0093 251
🇨🇿Praha 6, Czechia
Ep0093 275
🇪🇪Tartu, Estonia
Ep0093 307
🇫🇷Clermont-Ferrand, France
Ep0093 309
🇫🇷Dijon, France
Ep0093 301
🇫🇷Strasbourg, France
Ep0093 356
🇩🇪Osnabrück, Germany
Ep0093 302
🇫🇷Montpellier, France
Ep0093 362
🇩🇪Bernau, Germany
Ep0093 368
🇩🇪Jena, Germany
Ep0093 360
🇩🇪Freiburg, Germany
Ep0093 353
🇩🇪Marburg, Germany
Ep0093 450
🇮🇹Cagliari, Italy
Ep0093 452
🇮🇹Milano, Italy
Ep0093 352
🇩🇪Tübingen, Germany
Ep0093 426
🇬🇷Thessaloníki, Greece
Ep0093 427
🇬🇷Thessaloníki, Greece
Ep0093 351
🇩🇪Münster, Germany
Ep0093 366
🇩🇪Kehl, Germany
Ep0093 402
🇭🇺Debrecen, Hungary
Ep0093 462
🇮🇹Bologna, Italy
Ep0093 451
🇮🇹Foggia, Italy
Ep0093 461
🇮🇹Foggia, Italy
Ep0093 458
🇮🇹Pozzilli, Italy
Ep0093 457
🇮🇹Roma, Italy
Ep0093 400
🇭🇺Budapest, Hungary
Ep0093 403
🇭🇺Budapest, Hungary
Ep0093 035
🇮🇪Cork, Ireland
Ep0093 455
🇮🇹Roma, Italy
Ep0093 526
🇯🇵Asahikawa, Japan
Ep0093 459
🇮🇹Pavia, Italy
Ep0093 460
🇮🇹Roma, Italy
Ep0093 501
🇯🇵Asaka, Japan
Ep0093 512
🇯🇵Nagakute, Japan
Ep0093 521
🇯🇵Bunkyō-Ku, Japan
Ep0093 511
🇯🇵Fukuoka, Japan
Ep0093 504
🇯🇵Hamamatsu, Japan
Ep0093 004
🇸🇰Bardejov, Slovakia
Ep0093 651
🇪🇸Barcelona, Spain
Ep0093 505
🇯🇵Hiroshima, Japan
Ep0093 507
🇯🇵Itami, Japan
Ep0093 703
🇱🇹Kaunas, Lithuania
Ep0093 702
🇱🇹Vilnius, Lithuania
Ep0093 553
🇲🇽Culiacán, Mexico
Ep0093 607
🇵🇱Grodzisk Mazowiecki, Poland
Ep0093 513
🇯🇵Hōfu, Japan
Ep0093 514
🇯🇵Kyoto, Japan
Ep0093 515
🇯🇵Saitama, Japan
Ep0093 529
🇯🇵Yonago, Japan
Ep0093 601
🇵🇱Gdańsk, Poland
Ep0093 603
🇵🇱Kraków, Poland
Ep0093 509
🇯🇵Shizuoka, Japan
Ep0093 614
🇵🇱Kraków, Poland
Ep0093 610
🇵🇱Lublin, Poland
Ep0093 552
🇲🇽Mexico, Mexico
Ep0093 605
🇵🇱Katowice, Poland
Ep0093 606
🇵🇱Nowa Sól, Poland
Ep0093 604
🇵🇱Lublin, Poland
Ep0093 662
🇪🇸Alicante, Spain
Ep0093 652
🇪🇸Barcelona, Spain
Ep0093 664
🇪🇸Barcelona, Spain
Ep0093 667
🇪🇸Madrid, Spain
Ep0093 752
🇬🇧Birmingham, United Kingdom
Ep0093 764
🇬🇧Swansea, United Kingdom
Ep0093 674
🇪🇸Madrid, Spain
Ep0093 659
🇪🇸Málaga, Spain
Ep0093 901
🇹🇷Istanbul, Turkey
Ep0093 766
🇬🇧Brighton, United Kingdom
Ep0093 900
🇹🇷Istanbul, Turkey
Ep0093 653
🇪🇸Valladolid, Spain
Ep0093 904
🇹🇷Istanbul, Turkey
Ep0093 751
🇬🇧Swansea, United Kingdom
Ep0093 906
🇹🇷Istanbul, Turkey
Ep0093 909
🇹🇷Istanbul, Turkey
Ep0093 365
🇩🇪Berlin, Germany
Ep0093 358
🇩🇪Bonn, Germany
Ep0093 350
🇩🇪Frankfurt, Germany
Ep0093 357
🇩🇪Leipzig, Germany
Ep0093 354
🇩🇪München, Germany
Ep0093 801
🇺🇸San Francisco, California, United States
Ep0093 818
🇺🇸Bethesda, Maryland, United States
Ep0093 835
🇺🇸Nashville, Tennessee, United States
Ep0093 870
🇺🇸San Antonio, Texas, United States
Ep0093 660
🇪🇸Madrid, Spain
Ep0093 668
🇪🇸Barakaldo, Spain
Ep0093 666
🇪🇸Córdoba, Spain
Ep0093 665
🇪🇸Terrassa, Spain
Ep0093 852
🇦🇺Melbourne, Australia
Ep0093 253
🇨🇿Praha, Czechia
Ep0093 815
🇺🇸La Jolla, California, United States
Ep0093 890
🇺🇸Chapel Hill, North Carolina, United States
Ep0093 803
🇺🇸Honolulu, Hawaii, United States
Ep0093 805
🇺🇸Austin, Texas, United States
Ep0093 844
🇺🇸Austin, Texas, United States