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

Focal Epilepsy Clinical Trial

— ENACT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05481905
• Other study ID #: ENX-101-005
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2022
• Source: Engrail Therapeutics INC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Focal Epilepsy
• Seizures

Intervention

Drug:
• ENX-101
Adjunctive treatment to current antiseizure medication

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Advanced Clinical Research Center	Bridgeton	Missouri
United States	Montefiore Medical Center	Bronx	New York
United States	NeuroScience Research Center, LLC	Canton	Ohio
United States	Atrium Health	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Duke University School of Medicine	Durham	North Carolina
United States	Oakland University William Beaumont School of Medicine	Farmington Hills	Michigan
United States	University of Florida Research Institute of Orlando	Gainesville	Florida
United States	Northeast Regional Epilepsy Group	Hackensack	New Jersey
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	University of Kansas	Kansas City	Kansas
United States	Saint Joseph Health System	Lexington	Kentucky
United States	Somnos Clinical Research/Neurology Associates	Lincoln	Nebraska
United States	Institute of Neurology and Neurosurgery at Saint Barnabas LLC	Livingston	New Jersey
United States	D&H National Research Centers	Miami	Florida
United States	Royal Care Medical Research Corporation	Miami	Florida
United States	S&G Research Center Corp.	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Donald and Barbara Zucker School of Medicine at Hofstra/Northwell	New York	New York
United States	Comprehensive Neurology Clinic	Orlando	Florida
United States	Florida Hospital	Orlando	Florida
United States	OSF HealthCare Illinois Neurological Institute	Peoria	Illinois
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	SRI International	Plymouth	Michigan
United States	University of Rochester	Rochester	New York
United States	DJL Clinical Research	Rock Hill	South Carolina
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Maine Medical Partners Neurology	Scarborough	Maine
United States	Mt. Olympus Medical Research	Sugar Land	Texas
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Engrail Therapeutics INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures	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)	Treatment Period (Day 1 to Day 56) compared to placebo
Secondary	To evaluate the efficacy of ENX-101	The percent of patients who are seizure free during the last 28 days of the Treatment Period	Treatment Period (Day 29 to Day 56) compared to placebo
Secondary	To evaluate the efficacy of ENX-101	The percent of patients who are seizure free during the entire Treatment Period	Treatment Period (Day 1 to Day 56) compared to placebo