ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Focal Epilepsy

In brief

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.

Key facts

Study ID

NCT05481905

Run by

Engrail Therapeutics INC

People needed

0

Starts

2022-09-01

Expected to finish

2024-12-01

Last updated by the study team

2023-07-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center — Downey, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Florida Research Institute of Orlando — Gainesville, Florida, United States
• Royal Care Medical Research Corporation — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• D&H National Research Centers — Miami, Florida, United States
• S&G Research Center Corp. — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Comprehensive Neurology Clinic — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• OSF HealthCare Illinois Neurological Institute — Peoria, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Saint Joseph Health System — Lexington, Kentucky, United States
• Maine Medical Partners Neurology — Scarborough, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Oakland University William Beaumont School of Medicine — Farmington Hills, Michigan, United States
• SRI International — Plymouth, Michigan, United States
• Advanced Clinical Research Center — Bridgeton, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Somnos Clinical Research/Neurology Associates — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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