Status and phase
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About
The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.
Sex
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Volunteers
Inclusion criteria
Male or female aged 18 to 75 years, inclusive, at Screening
Diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification of Epilepsy, as confirmed by the Epilepsy Study Consortium
Able to provide an imaging study(ies) [magnetic resonance imaging (MRI) scan strongly preferred yet computed tomography (CT) acceptable] obtained within the previous 10 years that can rule out a progressive cause of epilepsy
During the 3 months (84 days) immediately prior to Screening:
During the 8-week Baseline Period prior to Day 1:
Has been treated with antiseizure medications (ASMs) ≥ 2 years and currently being treated with:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 3 patient groups, including a placebo group
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Central trial contact
Eve Taylor, PhD
Data sourced from clinicaltrials.gov
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