跳至主要内容
临床试验/NCT06149663
NCT06149663Available不适用

Expanded Access Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)

Longboard Pharmaceuticals22 个研究点 分布在 2 个国家开始时间: 2023年11月29日最近更新:
相关药物

试验速览

阶段
不适用
状态
Available
试验地点
22

研究概览

简要总结

This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs. The EAP study will allow continued treatment with LP352 for eligible participants diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation) or an immediate family member who has the exact same gene mutation resulting in the same DEE epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin EAP.

研究设计

研究类型
Expanded Access

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

入选标准

  • Participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (<18 years of age) as required by local regulations.
  • Participant with DEE who has successfully completed an LP352 Clinical Trial.
  • Participant currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician.
  • Participant currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.

排除标准

  • Participant was discontinued from an LP352 Clinical Trial for any reason.
  • Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (22)

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