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

Stopped early · Phase 2

Conditions studied: Drug-Resistant Epilepsy, Focal-Onset Seizures

In brief

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.

Key facts

Study ID

NCT03370120

Run by

UCB Biopharma SRL

People needed

406

Starts

2018-08-27

Expected to finish

2020-12-11

Last updated by the study team

2021-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 Subjects will be withdrawn from the study as soon as pregnancy is known.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

Where it is running

• 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 839 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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