Enrolling Now - 8
Protocol EP0091
A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study To Evaluate the Efficacy And Safety of Padsevonil As Adjuntive Treatment of Focal-Onset Seizures In Adult Subjects with Drug-Resistant Epilepsy.
Sponsor: UCB Pharma
PI: Marcelo Lancman, MD
INCLUSION: (all should be YES)
1 Is ≥ 18 years of age?
2 Has observable focal-onset (1A1, 1B, and 1C) seizures (as confirmed) for at least 3 years, with a video electroencephalography (VEEG) report or record confirming that diagnosis is available?
3 Has, on average, 4 or more spontaneous and observable focal-onset seizures per 28 days?
4 Has failed to achieve seizure control with 4 or more tolerated, and appropriately chosen, prior anti-epileptic drug (AED) regimens of adequate dose and duration, including past and ongoing treatment?
5 Is currently treated with a stable dose of at least 1, and up to 3, AEDs for the last 8 weeks?
EXCLUSION (all should be NO)
1 Had epilepsy surgery within 6 months?
2 Has a history of, or signs for, idiopathic generalized (genetic) epilepsy?
3 Has a neurostimulation device for epilepsy implanted for < 1 year, or its parameters are not stable for > 3 months?
4 Has used GABA-A-ergic drugs, including agonists (i.e. barbiturates) or receptor-positive allosteric modulators (i.e. benzodiazepine (BZDs) or non-BZDs), excluding GABA-A-ergic AEDs taken more than 2 times per week for any indication
5 Current use of benzodiazepines with an indication for epileptic seizures, such as clonazepam or clobazam
6 Has been taking Vigabatrin for less than 2 years, Retigabin for less than 4 years, or Felbamate for less than 1 year
7 Use of strong CYP3A4 enzyme inhibitors/inducers (AED and non-AED) including AEDs, such as carbamazepine, phenytoin, phenobarbital, and primidone; and non-AEDs, such as prescription or non-prescription drugs, medical cannabis, cannabidiol, and dietary supplements (e.g. St. John's wort, grapefruit, or passion fruit)