TerminatedPhase 2

An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure

Belgium, Bulgaria, Germany42 participantsStarted 2015-12-03

Plain-language summary

The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Prolonged QTc (Bazett's, machine-read) interval defined as \> 450 ms for males and \> 470 ms for females
. Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval \>= 220 ms)
. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
. In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) From the Beginning at Entry Visit (EV) of the Evaluation Period to End of Safety Follow-Up Visit During the EP0073 Study

Timeframe: From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)

75% Responder Rate by 3-month Interval (Month 0 to 3) Over the Evaluation Period

Timeframe: Over 3-month interval over the Evaluation Period (Month 0-3)

75% Responder Rate by 3-month Interval (Month >3-6) Over the Evaluation Period

Timeframe: Over 3-month interval over the Evaluation Period (Month >3-6)

75% Responder Rate by 3-month Interval (Month >6-9) Over the Evaluation Period

Timeframe: Over 3-month interval over the Evaluation Period (Month >6-9)

75% Responder Rate by 3-month Interval (Month >9-12) Over the Evaluation Period

Timeframe: Over 3-month interval over the Evaluation Period (Month >9-12)

75% Responder Rate by 3-month Interval (Month >12-15) Over the Evaluation Period

Timeframe: Over 3-month interval over the Evaluation Period (Month >12-15)

Trial details

NCT IDNCT02625090

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-24

Results submitted2021-11-23

View on ClinicalTrials.gov More Highly Drug-resistant Focal Epilepsy trials