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

NCT05481905 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: ENX-101-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 38

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.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures

  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

  Day 1 to end of the Treatment Period (Day 56) compared to placebo

Secondary Outcomes (3)

• 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

• To evaluate the efficacy of ENX-101

  Treatment Period (Day 29 to Day 56) compared to placebo

• To evaluate the efficacy of ENX-101

  Treatment Period (Day 1 to Day 56) compared to placebo

Study Arms (3)

ENX-101 15mg daily

EXPERIMENTAL

Drug: ENX-101

ENX-101 30mg daily

EXPERIMENTAL

Drug: ENX-101

Placebo daily

PLACEBO COMPARATOR

Drug: ENX-101

Interventions

ENX-101 DRUG

Adjunctive treatment to current antiseizure medication

ENX-101 15mg daily; ENX-101 30mg daily; Placebo daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Engrail Therapeutics INC: lead

Study Sites (38)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida Research Institute of Orlando

Gainesville, Florida, 32611, United States

Location

Royal Care Medical Research Corporation

Miami, Florida, 33032, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

S&G Research Center Corp.

Miami, Florida, 33155, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Comprehensive Neurology Clinic

Orlando, Florida, 32825, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

OSF HealthCare Illinois Neurological Institute

Peoria, Illinois, 61603, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Saint Joseph Health System

Lexington, Kentucky, 40504, United States

Location

Maine Medical Partners Neurology

Scarborough, Maine, 04074, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Oakland University William Beaumont School of Medicine

Farmington Hills, Michigan, 48334, United States

Location

SRI International

Plymouth, Michigan, 48170, United States

Location

Advanced Clinical Research Center

Bridgeton, Missouri, 63044, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Somnos Clinical Research/Neurology Associates

Lincoln, Nebraska, 68510, United States

Location

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

Institute of Neurology and Neurosurgery at Saint Barnabas LLC

Livingston, New Jersey, 07039, United States

Location

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Atrium Health

Chapel Hill, North Carolina, 28204, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

NeuroScience Research Center, LLC

Canton, Ohio, 44718, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 42101, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

DJL Clinical Research

Rock Hill, South Carolina, 29732, United States

Location

Mt. Olympus Medical Research

Sugar Land, Texas, 77479, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2022-07

Locations

US (38)