Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

Drug-Resistant Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03370120
• Other study ID #: EP0093
• Secondary ID: 2017-003241-26
• Status: Terminated
• Phase: Phase 2
• Start date: August 27, 2018
• Est. completion date: December 11, 2020

Study information

• Verified date: November 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 406
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Subjects will be withdrawn from the study as soon as pregnancy is known.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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Drug-Resistant Epilepsy
• Epilepsy
• Focal-Onset Seizures
• Seizures

Intervention

Drug:
• Padsevonil
Pharmaceutical Form: film-coated tablet Route of Administration: Oral use

Locations

Country	Name	City	State
Australia	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
Belgium	Ep0093 102	Brugge
Belgium	Ep0093 101	Brussels
Belgium	Ep0093 105	Gent
Belgium	Ep0093 100	Leuven
Belgium	Ep0093 107	Ottignies
Bosnia and Herzegovina	Ep0093 075	Sarajevo
Bosnia and Herzegovina	Ep0093 082	Tuzla
Bulgaria	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
Canada	Ep0093 200	Greenfield Park
Canada	Ep0093 205	London
Canada	Ep0093 201	Montréal
Croatia	Ep0093 125	Zagreb
Czechia	Ep0093 254	Brno
Czechia	Ep0093 255	Ostrava
Czechia	Ep0093 250	Praha
Czechia	Ep0093 253	Praha
Czechia	Ep0093 251	Praha 6
Denmark	Ep0093 016	Aarhus
Denmark	Ep0093 015	Odense
Estonia	Ep0093 276	Tallin
Estonia	Ep0093 277	Tallinn
Estonia	Ep0093 275	Tartu
Finland	Ep0093 027	Tampere
France	Ep0093 307	Clermont-Ferrand
France	Ep0093 309	Dijon
France	Ep0093 300	Lille
France	Ep0093 302	Montpellier
France	Ep0093 303	Rennes
France	Ep0093 301	Strasbourg
Germany	Ep0093 365	Berlin
Germany	Ep0093 362	Bernau
Germany	Ep0093 363	Bielefeld
Germany	Ep0093 358	Bonn
Germany	Ep0093 350	Frankfurt
Germany	Ep0093 360	Freiburg
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
Greece	Ep0093 426	Thessaloníki
Greece	Ep0093 427	Thessaloníki
Hungary	Ep0093 400	Budapest
Hungary	Ep0093 403	Budapest
Hungary	Ep0093 402	Debrecen
Ireland	Ep0093 035	Cork
Italy	Ep0093 462	Bologna
Italy	Ep0093 450	Cagliari
Italy	Ep0093 451	Foggia
Italy	Ep0093 461	Foggia
Italy	Ep0093 452	Milano
Italy	Ep0093 459	Pavia
Italy	Ep0093 458	Pozzilli
Italy	Ep0093 455	Roma
Italy	Ep0093 457	Roma
Italy	Ep0093 460	Roma
Japan	Ep0093 526	Asahikawa
Japan	Ep0093 501	Asaka
Japan	Ep0093 521	Bunkyo-Ku
Japan	Ep0093 511	Fukuoka
Japan	Ep0093 504	Hamamatsu
Japan	Ep0093 505	Hiroshima
Japan	Ep0093 513	Hofu
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
Lithuania	Ep0093 703	Kaunas
Lithuania	Ep0093 702	Vilnius
Mexico	Ep0093 553	Culiacán
Mexico	Ep0093 552	Mexico
Poland	Ep0093 601	Gdansk
Poland	Ep0093 607	Grodzisk Mazowiecki
Poland	Ep0093 605	Katowice
Poland	Ep0093 616	Katowice
Poland	Ep0093 603	Kraków
Poland	Ep0093 614	Kraków
Poland	Ep0093 604	Lublin
Poland	Ep0093 610	Lublin
Poland	Ep0093 606	Nowa Sól
Poland	Ep0093 600	Poznan
Poland	Ep0093 609	Poznan
Poland	Ep0093 602	Swidnik
Romania	Ep0093 926	Bucuresti
Serbia	Ep0093 327	Belgrade
Slovakia	Ep0093 004	Bardejov
Spain	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	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
Turkey	Ep0093 900	Istanbul
Turkey	Ep0093 901	Istanbul
Turkey	Ep0093 904	Istanbul
Turkey	Ep0093 906	Istanbul
Turkey	Ep0093 909	Istanbul
United Kingdom	Ep0093 752	Birmingham
United Kingdom	Ep0093 766	Brighton
United Kingdom	Ep0093 751	Swansea
United Kingdom	Ep0093 753	Swansea
United Kingdom	Ep0093 764	Swansea
United States	Ep0093 805	Austin	Texas
United States	Ep0093 844	Austin	Texas
United States	Ep0093 822	Baltimore	Maryland
United States	Ep0093 818	Bethesda	Maryland
United States	Ep0093 889	Boston	Massachusetts
United States	Ep0093 895	Bronx	New York
United States	Ep0093 839	Chandler	Arizona
United States	Ep0093 890	Chapel Hill	North Carolina
United States	Ep0093 884	Charlotte	North Carolina
United States	Ep0093 642	Columbia	Ohio
United States	Ep0093 838	Cordova	Tennessee
United States	Ep0093 638	Fort Wayne	Indiana
United States	Ep0093 645	Golden Valley	Minnesota
United States	Ep0093 806	Hackensack	New Jersey
United States	Ep0093 803	Honolulu	Hawaii
United States	Ep0093 815	La Jolla	California
United States	Ep0093 707	Lexington	Kentucky
United States	Ep0093 835	Nashville	Tennessee
United States	Ep0093 802	Philadelphia	Pennsylvania
United States	Ep0093 639	Renton	Washington
United States	Ep0093 824	Round Rock	Texas
United States	Ep0093 817	Saint Paul	Minnesota
United States	Ep0093 870	San Antonio	Texas
United States	Ep0093 801	San Francisco	California
United States	Ep0093 893	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Japan,  Lithuania,  Mexico,  Poland,  Romania,  Serbia,  Slovakia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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