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

E

Engrail Therapeutics

Status and phase

Withdrawn
Phase 2

Conditions

Focal Epilepsy

Treatments

Drug: ENX-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT05481905
ENX-101-005

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 3 patient groups, including a placebo group

ENX-101 15mg daily
Experimental group
Treatment:
Drug: ENX-101
ENX-101 30mg daily
Experimental group
Treatment:
Drug: ENX-101
Placebo daily
Placebo Comparator group
Treatment:
Drug: ENX-101

Trial contacts and locations

38

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Central trial contact

Eve Taylor, PhD

Data sourced from clinicaltrials.gov

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