ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Where in United States
- Ann Arbor · University of MichiganUnknown status
- Atlanta · Emory University School of MedicineUnknown status
- Aurora · University of ColoradoUnknown status
- Baltimore · University of Maryland Medical CenterUnknown status
- Bethesda · Mid-Atlantic Epilepsy and Sleep CenterUnknown status
- Bridgeton · Advanced Clinical Research CenterUnknown status
- Canton · NeuroScience Research Center LLCUnknown status
- Chapel Hill · Atrium HealthUnknown status
- Charlottesville · University of VirginiaUnknown status
- Downey · Rancho Research Institute at Rancho Los Amigos National Rehabilitation CenterUnknown status
- Durham · Duke University School of MedicineUnknown status
- Farmington Hills · Oakland University William Beaumont School of MedicineUnknown status
- Gainesville · University of Florida Research Institute of OrlandoUnknown status
- Hackensack · Northeast Regional Epilepsy GroupUnknown status
- Honolulu · Hawaii Pacific NeuroscienceUnknown status
- Kansas City · University of KansasUnknown status
- Lexington · Saint Joseph Health SystemUnknown status
- Lincoln · Somnos Clinical Research/Neurology AssociatesUnknown status
- Livingston · Institute of Neurology and Neurosurgery at Saint Barnabas, LLCUnknown status
- Miami · D&H National Research CentersUnknown status
- Miami · Royal Care Medical Research CorporationUnknown status
- Miami · S&G Research Center Corp.Unknown status
- Miami · University of MiamiUnknown status
- New York · Donald and Barbara Zucker School of Medicine at Hofstra/NorthwellUnknown status
- Orlando · Comprehensive Neurology ClinicUnknown status
- Orlando · Florida HospitalUnknown status
- Peoria · OSF HealthCare Illinois Neurological InstituteUnknown status
- Philadelphia · Thomas Jefferson UniversityUnknown status
- Phoenix · Barrow Neurological InstituteUnknown status
- Pittsburgh · University of PittsburghUnknown status
- Plymouth · SRI InternationalUnknown status
- Rochester · University of RochesterUnknown status
- Rock Hill · DJL Clinical ResearchUnknown status
- Scarborough · Maine Medical Partners NeurologyUnknown status
- St Louis · Washington University School of MedicineUnknown status
- Sugar Land · Mt. Olympus Medical ResearchUnknown status
- The Bronx · Montefiore Medical CenterUnknown status
- Tucson · University of ArizonaUnknown status
The registry text, word for word
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
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.
Inclusion: 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.
Exclusion: 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 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; 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 psychogenic non-epileptic seizures.