Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
Launched by UCB BIOPHARMA SRL · Dec 7, 2017
Trial Information
Current as of May 07, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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 Subjects will be withdrawn from the study as soon as pregnancy is known.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
About Ucb Biopharma Srl
UCB Biopharma Srl is a global biopharmaceutical company dedicated to the discovery and development of innovative therapies for patients with severe diseases, particularly in the fields of neurology and immunology. With a strong commitment to research and development, UCB leverages cutting-edge science and patient insights to create effective treatment solutions that improve the quality of life for individuals affected by complex conditions. The company fosters collaboration with healthcare professionals and stakeholders to advance its clinical programs and bring new therapies to market, underscoring its mission to transform patient care through science-driven approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chandler, Arizona, United States
La Jolla, California, United States
San Francisco, California, United States
Honolulu, Hawaii, United States
Fort Wayne, Indiana, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Golden Valley, Minnesota, United States
Saint Paul, Minnesota, United States
Hackensack, New Jersey, United States
Bronx, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Columbia, Ohio, United States
Philadelphia, Pennsylvania, United States
Cordova, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Renton, Washington, United States
Box Hill, , Australia
Clayton, , Australia
Fitzroy, , Australia
Heidelberg, , Australia
Herston, , Australia
Melbourne, , Australia
Randwick, , Australia
Westmead, , Australia
Brugge, , Belgium
Brussels, , Belgium
Gent, , Belgium
Leuven, , Belgium
Ottignies, , Belgium
Sarajevo, , Bosnia And Herzegovina
Tuzla, , Bosnia And Herzegovina
Blagoevgrad, , Bulgaria
Pleven, , Bulgaria
Pleven, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Greenfield Park, , Canada
London, , Canada
Montréal, , Canada
Zagreb, , Croatia
Brno, , Czechia
Ostrava, , Czechia
Praha 6, , Czechia
Praha, , Czechia
Praha, , Czechia
Aarhus, , Denmark
Odense, , Denmark
Tallinn, , Estonia
Tallin, , Estonia
Tartu, , Estonia
Tampere, , Finland
Clermont Ferrand, , France
Dijon, , France
Lille, , France
Montpellier, , France
Rennes, , France
Strasbourg, , France
Berlin, , Germany
Bernau, , Germany
Bielefeld, , Germany
Bonn, , Germany
Frankfurt, , Germany
Freiburg, , Germany
Jena, , Germany
Kehl, , Germany
Leipzig, , Germany
Marburg, , Germany
München, , Germany
Münster, , Germany
Osnabrück, , Germany
Tübingen, , Germany
Thessaloníki, , Greece
Thessaloníki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Cork, , Ireland
Bologna, , Italy
Cagliari, , Italy
Foggia, , Italy
Foggia, , Italy
Milano, , Italy
Pavia, , Italy
Pozzilli, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Asahikawa, , Japan
Asaka, , Japan
Bunkyō Ku, , Japan
Fukuoka, , Japan
Hamamatsu, , Japan
Hiroshima, , Japan
Hōfu, , Japan
Itami, , Japan
Kyoto, , Japan
Nagakute, , Japan
Niigata, , Japan
Saitama, , Japan
Shizuoka, , Japan
Yonago, , Japan
Kaunas, , Lithuania
Vilnius, , Lithuania
Culiacán, , Mexico
Mexico, , Mexico
Gdańsk, , Poland
Grodzisk Mazowiecki, , Poland
Katowice, , Poland
Katowice, , Poland
Kraków, , Poland
Kraków, , Poland
Lublin, , Poland
Lublin, , Poland
Nowa Sól, , Poland
Poznań, , Poland
Poznań, , Poland
świdnik, , Poland
Bucuresti, , Romania
Belgrade, , Serbia
Bardejov, , Slovakia
Alicante, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Hospitalet De Llobregat, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Terrassa, , Spain
Valencia, , Spain
Valladolid, , Spain
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Birmingham, , United Kingdom
Brighton, , United Kingdom
Swansea, , United Kingdom
Swansea, , United Kingdom
Swansea, , United Kingdom
Patients applied
Trial Officials
UCB Cares
Study Director
001 844 599 2273 (UCB)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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