Study Stopped
Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
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
2 other identifiers
interventional
406
26 countries
141
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2018
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedStudy Start
First participant enrolled
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2020
CompletedResults Posted
Study results publicly available
December 29, 2021
CompletedDecember 29, 2021
November 1, 2021
2.3 years
December 7, 2017
November 30, 2021
November 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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.
From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal
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.
From Entry Visit (Week 0) until the Safety Follow-up Visit (up to approximately 2 years)
Change From Baseline (From the Respective Parent Study [EP0091 or EP0092]) in Observable Focal-onset Seizure Frequency Over the Evaluation Period
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.
From Baseline in respective parent study over the Evaluation Period (up to approximately 2 years) in this study
Study Arms (1)
Padsevonil
EXPERIMENTALPadsevonil 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.
Interventions
* Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (156)
Ep0093 839
Chandler, Arizona, 85226, United States
Ep0093 815
La Jolla, California, 92037, United States
Ep0093 801
San Francisco, California, 94115, United States
Ep0093 803
Honolulu, Hawaii, 96817, United States
Ep0093 638
Fort Wayne, Indiana, 46804, United States
Ep0093 707
Lexington, Kentucky, 40536, United States
Ep0093 822
Baltimore, Maryland, 21287, United States
Ep0093 818
Bethesda, Maryland, 20817, United States
Ep0093 889
Boston, Massachusetts, 02215, United States
Ep0093 645
Golden Valley, Minnesota, 55422, United States
Ep0093 817
Saint Paul, Minnesota, 55102, United States
Ep0093 806
Hackensack, New Jersey, 07601, United States
Ep0093 893
Syracuse, New York, 13210, United States
Ep0093 895
The Bronx, New York, 10467-24 01, United States
Ep0093 890
Chapel Hill, North Carolina, 27514, United States
Ep0093 884
Charlotte, North Carolina, 28204, United States
Ep0093 642
Columbia, Ohio, 43210, United States
Ep0093 802
Philadelphia, Pennsylvania, 19107, United States
Ep0093 838
Cordova, Tennessee, 38018, United States
Ep0093 835
Nashville, Tennessee, 37232, United States
Ep0093 805
Austin, Texas, 78701, United States
Ep0093 844
Austin, Texas, 78758, United States
Ep0093 824
Round Rock, Texas, 78681, United States
Ep0093 870
San Antonio, Texas, 78229, United States
Ep0093 639
Renton, Washington, 98055, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2017
First Posted
December 12, 2017
Study Start
August 27, 2018
Primary Completion
December 11, 2020
Study Completion
December 11, 2020
Last Updated
December 29, 2021
Results First Posted
December 29, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.