NCT06719141进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 367
- 试验地点
- 279
- 主要终点
- Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
研究概览
简要总结
This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:
- •Onset of seizures at ≤8 years old
- •History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms
- •Presence of developmental plateauing or regression
- •History of electroencephalogram (EEG) showing generalized slow (<2.5 Hertz [Hz]) spike-and-wave complexes
- •Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:
- •Does not meet criteria for LGS
- •Onset of seizures at ≤5 years old
- •Presence of developmental plateauing or regression
- •History of multiple seizure types
- •History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)
- •The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic.
- •The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening.
- •The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
- •The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
- •The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative.
排除标准
- •The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.
- •The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
- •The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
- •The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
- •The participant is receiving exclusionary medications.
- •The participant is currently using any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
- •The participant has unstable, clinically significant neurologic (other than the disease being studied; eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- •The participant is unable or unwilling to comply with any of the study requirements or timelines.
研究组 & 干预措施
LP352
Experimental
Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.
干预措施: LP352 (Drug)
Placebo
Placebo Comparator
Placebo for LP352
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
时间窗: Baseline and up to 15 Weeks
The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.
次要结局
- Safety and Tolerability of LP352(Up to 21 Weeks)
- Percentage of participants with ≥ 50% Reduction in countable motor seizures during the Treatment compared to Baseline(Baseline and up to 15 Weeks)
- Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline(Baseline and up to 15 Weeks)
研究者
研究点 (279)
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- The Phase III trial evaluates bexicaserin, an oral, highly selective 5-HT2C receptor superagonist, against placebo for reducing countable motor seizure frequency across diverse DEE syndromes including more than 60 genetic etiologies.
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