2026-527114-23-00招募中2 期
Pharmacodynamic Evaluation of OV329 in Participants with Epilepsy and a Photo-Induced Generalized Epileptiform EEG-Response Phase 2 Proof-of-Concept.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from Baseline in standardized photosensitivity range (SPR) on pre-dose Day 1 (placebo) to post-dose OV329 on several days
研究概览
简要总结
To evaluate the pharmacodynamic effect of OV329 on the IPS-induced PPR in participants with epilepsy, both after single oral dosing and after repeated dosing.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 to 65 years at the time of consent
- •Participants with a diagnosis and history of epilepsy (see exceptions in Exclusion Criteria).
- •Participants with a reproducible IPS-induced PPR of at least 4 points on a frequency assessment scale at Screening and Baseline.
排除标准
- •Participants with a history of non-epileptic seizures (e.g., metabolic or pseudo-seizures).
- •Participants with a diagnosis of Classical juvenile myoclonus epilepsy characterized by exclusively or predominantly early morning myoclonic seizures, as assessed by the investigator
- •Current use of vagus nerve stimulator or responsive neurostimulation is not permitted.
- •Participants who are taking or have taken OV329 as concomitant therapy within the last 3 months in other OV329 studies.
研究组 & 干预措施
OV329, OV329
Test
干预措施: OV329 (Drug)
结局指标
主要结局
Change from Baseline in standardized photosensitivity range (SPR) on pre-dose Day 1 (placebo) to post-dose OV329 on several days
Change from Baseline in standardized photosensitivity range (SPR) on pre-dose Day 1 (placebo) to post-dose OV329 on several days
次要结局
未报告次要终点
研究者
Julia Tsai
Scientific
Ovid Therapeutics Inc.
研究点 (1)
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