Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | February 12, 2018 |
End Date: | February 2020 |
Contact: | UCB Cares |
Email: | UCBCares@ucb.com |
Phone: | +1844599 |
A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
The purpose of the study is to characterize the dose-response relationship with respect to
efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs)
for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs)
for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
44
sites
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