NCT05481905撤回2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 38
- 主要终点
- To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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 psychogenic non-epileptic seizures
- •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
研究组 & 干预措施
ENX-101 15mg daily
Experimental
干预措施: ENX-101 (Drug)
ENX-101 30mg daily
Experimental
干预措施: ENX-101 (Drug)
Placebo daily
Placebo Comparator
干预措施: ENX-101 (Drug)
结局指标
主要结局
To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures
时间窗: Day 1 to end of the Treatment Period (Day 56) compared to placebo
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
次要结局
- To evaluate the efficacy of ENX-101 administered adjunctively with 1 to 4 antiseizure medications for the treatment of focal seizures(Treatment Period (Day 1 to Day 56) compared to placebo)
- To evaluate the efficacy of ENX-101(Treatment Period (Day 1 to Day 56) compared to placebo)
研究者
研究点 (38)
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