2024-516412-17-00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 Developmental and Epileptic Encephalopathies
Longboard Pharmaceuticals Inc.37 个研究点 分布在 8 个国家目标入组 102 人开始时间: 2025年6月11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
- 102
- 试验地点
- 37
- 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 Developmental and Epileptic Encephalopathy as assessed by countable motor seizures
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: o Onset of seizures at ≤8 years old o 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 o Presence of developmental plateauing or regression
- •Participants who are characterized as having DEE (Other) must fulfill all of the following criteria: o Does not meet criteria for LGS o Onset of seizures at ≤5 years old o Presence of developmental plateauing or regression o History of multiple seizure types
- •Additional specific main inclusion criteria include the following: o 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. o The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening. o The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening. o 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. o 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 must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study.
排除标准
- •The participant has a diagnosis of Dravet Syndrome (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 has used of 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.
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
- 1.• 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Maintenance 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 (37)
Loading locations...
相似试验
招募中
2 期
A multicenter study to evaluate the safety, tolerability and efficacy of XEN1101 as additional therapy to standard treatment in focal epilepsy, with an Open-label Extension.2023-508681-15-00Xenon Pharmaceuticals Inc.182
已完成
1 期
QTc Assessment in a Single-Dose Study of Hydronidone CapsulesHepatic FibrosisNCT07263152Beijing Continent Pharmaceutical Co, Ltd.48
招募中
2 期
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)Ulcerative ColitisNCT07265570InSilico Medicine Hong Kong Limited80
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyNCT07266805Pharvaris Netherlands B.V.32
招募中
1 期
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid ArthritisNCT07258849Eli Lilly and Company141