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

Stopped early · Phase 3 · Has a placebo group

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

In brief

The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

Key facts

Study ID

NCT03739840

Run by

UCB Biopharma SRL

People needed

232

Starts

2019-03-06

Expected to finish

2020-09-28

Last updated by the study team

2022-12-21

Who can join

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

You may qualify if…

• Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
• Subject has failed to achieve seizure control with >=4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
• Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
• Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments

You may not qualify if…

• Subject has a history of or signs of generalized or combined generalized and focal epilepsy
• Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
• Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
• Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
• Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
• Subject has been taking vigabatrin less than 2 years at study entry
• Subject has been taking felbamate for less than 12 months
• Subject taking retigabine for less than 4 years
• Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) <3 times per week for emergencies
• Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study

Where it is running

• Ep0092 881 — Tucson, Arizona, United States
• Ep0092 633 — Carlsbad, California, United States
• Ep0092 629 — Orange, California, United States
• Ep0092 845 — Washington D.C., District of Columbia, United States
• Ep0092 892 — Bradenton, Florida, United States
• Ep0092 640 — Hialeah, Florida, United States
• Ep0092 641 — Jacksonville, Florida, United States
• Ep0092 823 — Orlando, Florida, United States
• Ep0092 803 — Honolulu, Hawaii, United States
• Ep0092 637 — Urbana, Illinois, United States
• Ep0092 880 — Anderson, Indiana, United States
• Ep0092 638 — Fort Wayne, Indiana, United States
• Ep0092 630 — Ames, Iowa, United States
• Ep0092 707 — Lexington, Kentucky, United States
• Ep0092 822 — Baltimore, Maryland, United States
• Ep0092 818 — Bethesda, Maryland, United States
• Ep0092 889 — Boston, Massachusetts, United States
• Ep0092 645 — Golden Valley, Minnesota, United States
• Ep0092 644 — Minneapolis, Minnesota, United States
• Ep0092 878 — Brooklyn, New York, United States
• Ep0092 876 — New York, New York, United States
• Ep0092 893 — Syracuse, New York, United States
• Ep0092 895 — The Bronx, New York, United States
• Ep0092 890 — Chapel Hill, North Carolina, United States
• Ep0092 839 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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