2024-511388-27-04招募中2 期
Add-on Clioquinol in drug-resistant epilepsy: an exploratory study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of 50% responders after 2 weeks and 6 weeks exposure to low and higher doses of clioquinol respectively (visit 3 and visit 5)
研究概览
简要总结
To study whether add-on clioquinol decreases the seizure frequency and severity in patients with drug-resistant epilepsy.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Drug-resistant epilepsy: ≥ 4 seizures in the 2 week prospective period (baseline) before visit 2, not all (4) seizures observed in 1 of the 2 weeks. Baseline period can be extended with 1 or 2 weeks.
- •Age ≥ 12 years and < 35 years at time of inclusion
- •Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs
- •The patient is at the moment of inclusion on max 4 anti-epileptic drugs (VNS and ketogenic diet not included)
- •Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
排除标准
- •Presence of C609T NQO1 SNP after SNP analysis of NQO1 based on a blood sample during baseline visit (visit 1) by Genomics Core
- •Asian etnicity
- •Abnormal low blood level of vitamin B12 or Zn
结局指标
主要结局
Percentage of 50% responders after 2 weeks and 6 weeks exposure to low and higher doses of clioquinol respectively (visit 3 and visit 5)
Percentage of 50% responders after 2 weeks and 6 weeks exposure to low and higher doses of clioquinol respectively (visit 3 and visit 5)
Median % reduction of the seizure frequency at visit 5
Median % reduction of the seizure frequency at visit 5
次要结局
- Safety during trial (systematic recording of adverse events) Clinical neurological examination during the trial will identify children with possible neuropathy Adverse events will be reported (clinical and biochemical).
- Assessment of seizure severity (NHS3 scale)
- Assessment of overall impact of seizures, medication side effects, comorbidities, and overall QoL (PIES).
研究者
Prof. Dr. Lieven Lagae
Scientific
UZ Leuven
研究点 (1)
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