ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
- Registration Number
- NCT05481905
- Lead Sponsor
- Engrail Therapeutics INC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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:
- ≥ 3 observable focal onset seizures per 28-day period
- <10 seizures per day
- Any seizure-free interval no more than 21 days in length,
-
During the 8-week Baseline Period prior to Day 1:
- ≥ 6 observable focal onset seizures
- < 10 seizures per day
- No seizure-free interval of ≥ 21 days,
-
Has been treated with antiseizure medications (ASMs) ≥ 2 years and currently being treated with:
- One to 4 ASMs at stable doses for at least 28 days before Screening (not including the rescue medication)
- Dose adjustments not expected during study
- EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)
- Has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type
- Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome
- Has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to Screening
- Has history of psychogenic non-epileptic seizures
- Has history of status epilepticus within two years prior to Screening
- Treatment of epilepsy with ASM was initiated < 2 years prior to Screening
- Ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to Screening
- Had epilepsy surgery for tissue resection < 1 year prior to Screening or radiosurgery < 2 years prior to Screening
- Had Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS), or other neurostimulation for epilepsy device implanted or activated < 1 year prior to Screening, stimulation parameters have been stable for < 3 months, or battery life of unit not anticipated to extend for duration of trial
- Initiated dietary therapy for epilepsy (e.g., ketogenic diet) < 3 months prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ENX-101 15mg daily ENX-101 - ENX-101 30mg daily ENX-101 - Placebo daily ENX-101 -
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures Day 1 to end of the Treatment Period (Day 56) compared to placebo The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures Treatment Period (Day 1 to Day 56) compared to placebo The responder rate defined as the percent of patients who experience a 50% or greater reduction from baseline in seizure frequency in the Treatment Period compared to placebo (designated as primary for the European Medicines Agency)
To evaluate the efficacy of ENX-101 Treatment Period (Day 1 to Day 56) compared to placebo The percent of patients who are seizure free during the entire Treatment Period
Trial Locations
- Locations (38)
University of Miami
🇺🇸Miami, Florida, United States
University of Rochester
🇺🇸Rochester, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center
🇺🇸Downey, California, United States
Royal Care Medical Research Corporation
🇺🇸Miami, Florida, United States
D&H National Research Centers
🇺🇸Miami, Florida, United States
S&G Research Center Corp.
🇺🇸Miami, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
OSF HealthCare Illinois Neurological Institute
🇺🇸Peoria, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Oakland University William Beaumont School of Medicine
🇺🇸Farmington Hills, Michigan, United States
Advanced Clinical Research Center
🇺🇸Bridgeton, Missouri, United States
Institute of Neurology and Neurosurgery at Saint Barnabas LLC
🇺🇸Livingston, New Jersey, United States
Somnos Clinical Research/Neurology Associates
🇺🇸Lincoln, Nebraska, United States
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
🇺🇸New York, New York, United States
NeuroScience Research Center, LLC
🇺🇸Canton, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Mt. Olympus Medical Research
🇺🇸Sugar Land, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Maine Medical Partners Neurology
🇺🇸Scarborough, Maine, United States
Northeast Regional Epilepsy Group
🇺🇸Hackensack, New Jersey, United States
SRI International
🇺🇸Plymouth, Michigan, United States
DJL Clinical Research
🇺🇸Rock Hill, South Carolina, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Comprehensive Neurology Clinic
🇺🇸Orlando, Florida, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Atrium Health
🇺🇸Chapel Hill, North Carolina, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
University of Florida Research Institute of Orlando
🇺🇸Gainesville, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Saint Joseph Health System
🇺🇸Lexington, Kentucky, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States