ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Where in Egyesült Államok
- Ann Arbor · University of MichiganIsmeretlen állapot
- Atlanta · Emory University School of MedicineIsmeretlen állapot
- Aurora · University of ColoradoIsmeretlen állapot
- Baltimore · University of Maryland Medical CenterIsmeretlen állapot
- Bethesda · Mid-Atlantic Epilepsy and Sleep CenterIsmeretlen állapot
- Bridgeton · Advanced Clinical Research CenterIsmeretlen állapot
- Canton · NeuroScience Research Center LLCIsmeretlen állapot
- Chapel Hill · Atrium HealthIsmeretlen állapot
- Charlottesville · University of VirginiaIsmeretlen állapot
- Downey · Rancho Research Institute at Rancho Los Amigos National Rehabilitation CenterIsmeretlen állapot
- Durham · Duke University School of MedicineIsmeretlen állapot
- Farmington Hills · Oakland University William Beaumont School of MedicineIsmeretlen állapot
- Gainesville · University of Florida Research Institute of OrlandoIsmeretlen állapot
- Hackensack · Northeast Regional Epilepsy GroupIsmeretlen állapot
- Honolulu · Hawaii Pacific NeuroscienceIsmeretlen állapot
- Kansas City · University of KansasIsmeretlen állapot
- Lexington · Saint Joseph Health SystemIsmeretlen állapot
- Lincoln · Somnos Clinical Research/Neurology AssociatesIsmeretlen állapot
- Livingston · Institute of Neurology and Neurosurgery at Saint Barnabas, LLCIsmeretlen állapot
- Miami · D&H National Research CentersIsmeretlen állapot
- Miami · Royal Care Medical Research CorporationIsmeretlen állapot
- Miami · S&G Research Center Corp.Ismeretlen állapot
- Miami · University of MiamiIsmeretlen állapot
- New York · Donald and Barbara Zucker School of Medicine at Hofstra/NorthwellIsmeretlen állapot
- Orlando · Comprehensive Neurology ClinicIsmeretlen állapot
- Orlando · Florida HospitalIsmeretlen állapot
- Peoria · OSF HealthCare Illinois Neurological InstituteIsmeretlen állapot
- Philadelphia · Thomas Jefferson UniversityIsmeretlen állapot
- Phoenix · Barrow Neurological InstituteIsmeretlen állapot
- Pittsburgh · University of PittsburghIsmeretlen állapot
- Plymouth · SRI InternationalIsmeretlen állapot
- Rochester · University of RochesterIsmeretlen állapot
- Rock Hill · DJL Clinical ResearchIsmeretlen állapot
- Scarborough · Maine Medical Partners NeurologyIsmeretlen állapot
- St Louis · Washington University School of MedicineIsmeretlen állapot
- Sugar Land · Mt. Olympus Medical ResearchIsmeretlen állapot
- The Bronx · Montefiore Medical CenterIsmeretlen állapot
- Tucson · University of ArizonaIsmeretlen állapot
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.