Clinical trial NCT05481905: ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Official title: The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Focal Epilepsy
Lead sponsor: Engrail Therapeutics INC
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 to 75 years, inclusive, at Screening
2. 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
3. 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
4. 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,
5. 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,
6. 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

Exclusion Criteria:

1. EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)
2. 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
3. Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome
4. 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
5. Has history of psychogenic non-epileptic seizures
6. Has history of status epilepticus within two years prior to Screening
7. Treatment of epilepsy with ASM was initiated \< 2 years prior to Screening
8. Ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to Screening
9. Had epilepsy surgery for tissue resection \< 1 year prior to Screening or radiosurgery \< 2 years prior to Screening
10. 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
11. Initiated dietary therapy for epilepsy (e.g., ketogenic diet) \< 3 months prior to Screening

Primary outcomes:
measure: To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
timeFrame: Day 1 to end of the Treatment Period (Day 56) compared to placebo
Secondary outcomes:
measure: To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
timeFrame: Treatment Period (Day 1 to Day 56) compared to placebo
measure: To evaluate the efficacy of ENX-101
timeFrame: Treatment Period (Day 29 to Day 56) compared to placebo
measure: To evaluate the efficacy of ENX-101
timeFrame: Treatment Period (Day 1 to Day 56) compared to placebo
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Downey
country: United States
facility: Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Research Institute of Orlando
state: Florida
city: Miami
country: United States
facility: Royal Care Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Miami
country: United States
facility: S&G Research Center Corp.
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Comprehensive Neurology Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Peoria
country: United States
facility: OSF HealthCare Illinois Neurological Institute
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Lexington
country: United States
facility: Saint Joseph Health System
state: Kentucky
city: Scarborough
country: United States
facility: Maine Medical Partners Neurology
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Farmington Hills
country: United States
facility: Oakland University William Beaumont School of Medicine
state: Michigan
city: Plymouth
country: United States
facility: SRI International
state: Michigan
city: Bridgeton
country: United States
facility: Advanced Clinical Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research/Neurology Associates
state: Nebraska
city: Hackensack
country: United States
facility: Northeast Regional Epilepsy Group
state: New Jersey
city: Livingston
country: United States
facility: Institute of Neurology and Neurosurgery at Saint Barnabas LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Rock Hill
country: United States
facility: DJL Clinical Research
state: South Carolina
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: