Does BRV Have Faster Onset Time & Greater Effect Than LEV in Epilepsy Pts Using PPR Pharmacodynamic Efficacy Endpoint
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main purpose of this study is to see whether brivaracetam has a faster onset time and
      greater effect than levetiracetam in subjects with photosensitive seizures. Part 1 of the
      study will compare the effects of levetiracetam 1500 mg with the effects of brivaracetam 100
      mg. Part 2, will compare the effects of levetiracetam 1500 mg with the effects of
      brivaracetam 100 mg or will compare the effects of levetiracetam 500mg with the effects of
      brivaracetam 25 mg.
    

Detailed description: 
      The proposed study in epilepsy patients with photosensitivity intends to extend the animal
      findings for the faster (and perhaps greater) pharmacodynamic effect of intravenous BRV
      versus LEV at equipotent doses. Doses and infusion times were chosen based on proven safety
      profiles of both drugs (UCB, data on file): maximal dose of 1500 mg LEV in 15 minutes (or in
      5 minutes) and 100 mg for BRV (15 times more potency of BRV compared to LEV). The study
      proposes a comparison of the rapidity of the CNS effects of both LEV and BRV within the same
      patient (randomized, two-way crossover, double-blind in a total 16 patients with epilepsy 8
      patients in Part 1 and 8 patients in Part 2) Study Part 1: an IV infusion over 15 minutes,
      appropriately diluted (per package insert for LEV); BRV will also be administered as a
      15-minute infusion (anticipating similar language in the package insert for BRV);Study Part
      2, Option I: Assuming a statistically significant difference in the rapidity of CNS action
      has been observed from an analysis of the data set in Study Part 1, will proceed with Study
      Part 2 Option I. LEV or BRV will be administered, in a randomized, two-way crossover,
      double-blind design as an IV infusion over 5 minutes, appropriately diluted, to another
      cohort of 8 patients with photosensitive epilepsy. (Potentially, a few of the same patients
      as under 'a' above could participate herein, if they are willing to repeat the study). OR
      Study Part 2, Option II: Assuming no statistically significant difference in the rapidity of
      CNS action has been observed from an analysis of the data set in Study Part 1, will proceed
      with Study Part 2, Option II. LEV or BRV will be administered, in a randomized, two-way
      crossover, double-blind design as an IV infusion over again 15 minutes, appropriately
      diluted, to another cohort of 8 patients with photosensitive epilepsy. (Potentially, a few of
      the same patients as under 'a' above could participate herein, if they are willing to repeat
      the study). However, LEV will be given as a 500 mg dose, and BRV as a 25 mg dose. Use of
      lower, nearly equipotent minimally effective doses of LEV and BRV will maximize ability to
      readily differentiate the electroencephalographic PPR effect between the two AEDs.
    

Intervention name(s): BRV vs LEV in randomized double blinded, crossover fashion
Intervention type(s): Drug
Intervention description(s): Single dose intravenous administration of BRV 100 mg over a 15 minutes period. On a subsequent occasion, (approximately 2 weeks later), the patient is crossed over to the other drug at a singular dose. On both occasions, intermittent photic stimulation is done 10 times in a two hour period. IPS is again conducted in the cross over portion as well. Coincident with IPS stimulation 10 blood samples will be drawn for BRV or LEV plasma concentration.
Other intervention name(s): Intermit pho stim respect over 2 hours/each of 2 study days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment