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Antiepileptic Drug

Part 1 for Photosensitive Epilepsy

Phase 2 & 3
Waitlist Available
Led By William E Rosenfeld, M.D.
Research Sponsored by Rosenfeld, William E., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights

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.

Eligible Conditions
  • Photosensitive Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
"Comparison between Brivaracetam and Levetiracetam of the Time to Peak Effect (Abolition) and Time to >50% Diminution in Photo-Paroxysmal Response in Patients with Photosensitive Epilepsy" (1)
Secondary outcome measures
"Comparison between Brivaracetam and Levetiracetam of the Time to Peak Effect (Abolition) and Time to >50% Diminution in Photo-Paroxysmal Response in Patients with Photosensitive Epilepsy" (2)

Trial Design

2Treatment groups
Active Control
Group I: Part 1Active Control1 Intervention
Compare rapidity of CNS effects of levetiracetam (LEV) & brivaracetam (BRV) within same pt-(randomized, two-way crossover, dbl-blind in total 16 pts w/epilepsy. Pt 1: IV infusion over 15 min BRV will also be administered as 15-min.infusion. BRV vs LEV in randomized double blinded, crossover fashion.
Group II: Part 2Active Control1 Intervention
Pt 2 Op I:Assuming statistically signify. diff. in rapidity of CNS action has been observed from an analysis of data set in Pt 1,will proceed w/ Pt 2Opt I. Levetiracetam (LEV) or brivaracetam (BRV administered in randomized, two-way crossover, dbl-blind design as IV infusion over 5 min. to another cohort of 8 pts w/photosensitive epilepsy OR Pt 2,Opt II: Assuming no statistically signif. diff. in rapidity of CNS action has been observed from an analysis of data set in Pt 1, will proceed w/Pt 2,Opt II. LEV or BRV will be administered, in randomized, two-way crossover, dbl-blind design as IV infusion over again 15 min. to another cohort of 8 pts w/ photosensitive epilepsy. LEV will be given as 500 mg dose & BRV as 25 mg dose. BRV vs LEV in randomized double blinded, crossover fashion.

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Who is running the clinical trial?

PRA Health SciencesIndustry Sponsor
94 Previous Clinical Trials
42,329 Total Patients Enrolled
Utrecht UniversityOTHER
51 Previous Clinical Trials
30,032 Total Patients Enrolled
Comprehensive Epilepsy Care Center for Children & AdultsOTHER
~2 spots leftby Jul 2025
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