2024-514937-39-00招募中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 Dravet Syndrome
Longboard Pharmaceuticals Inc.32 个研究点 分布在 8 个国家目标入组 87 人开始时间: 2025年4月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 32
- 主要终点
- Frequency percent change in countable motor seizures during Maintenance compared to Baseline
研究概览
简要总结
To evaluate the efficacy of LP352 in Dravet Syndrome as assessed by countable motor seizures
研究设计
- 分配方式
- Randomized
- 主要目的
- Taper
- 盲法
- Double (Subject, Investigator, Analyst, Carer, Monitor)
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant is ≥2 to ≤65 years of age at the time of Screening
- •Diagnosis of Dravet Syndrome according to International League Against Epilepsy definition and must fulfill all of the following criteria: a. Onset of seizures age >1 and <20 months in an otherwise healthy infant. b. History of at least 1 of the following seizure type(s): i. Prolonged generalized tonic-clonic ii. Hemiclonic iii. Myoclonic iv. Tonic v. Atonic vi. Atypical absence vii. Focal awareness viii. Nonconvulsive status epilepticus
- •The following countable motor seizure types: a. Generalized tonic-clonic b. Tonic (bilateral) c. Clonic (bilateral) d. Atonic (bilateral) with truncal/leg involvement e. Focal motor (including hemiclonic) f. Focal to bilateral tonic-clonic
- •Demonstrated an average of at least 4 countable motor seizures (as per inclusion criterion 3) per month for the 3 months prior to Screening
- •Has been taking 1 to 4 ASMs at a stable dose for at least 4 weeks prior to Screening
- •The participant must be willing and able to provide written informed consent.
- •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.
排除标准
- •The participant has a history of infantile/epileptic spasms.
- •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, as described in the protocol.
- •The participant has used 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; e.g., recurrent strokes), psychiatric, cardiovascular (e.g., 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 unwilling to comply with any of the study requirements or timelines.
结局指标
主要结局
Frequency percent change in countable motor seizures during Maintenance compared to Baseline
Frequency percent change in countable motor seizures during Maintenance compared to Baseline
次要结局
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs), including Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation
- Safety laboratory parameters
- Physical examination findings
- Vital signs
- Growth parameters (height and weight)
- 12-lead Electrocardiogram (ECGs)
- Columbia-Suicide Severity Rating Scale (C-SSRS) responses
- Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score
- 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Treatment compared to Baseline
- Frequency percent change in countable motor seizures during Treatment compared to Baseline
研究者
Global Regulatory Lead
Scientific
Longboard Pharmaceuticals Inc.
研究点 (32)
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