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)
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
- 否
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
研究点 (22)
Loading locations...
相似试验
Available
不适用
Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 MutationAdvanced Non-small Cell Lung CancerCancerNCT06761976Bayer
No Longer Available
不适用
Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)Multiple System Atrophy (MSA)NCT05086094Biohaven Pharmaceuticals, Inc.
Available
不适用
TRx0237 for the Treatment of Early and Mild-Moderate Alzheimer's DiseaseAlzheimer DiseaseNCT03539380TauRx Therapeutics Ltd
Available
不适用
Expanded Access to Ensartinib for Participants With ALK+ NSCLCALK Gene Rearrangement PositiveNon-Small Cell Lung CancerNCT04146571Xcovery Holdings, Inc.
No Longer Available
不适用
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant PatientsSolid Organ Transplant RejectionOrgan Rejection TransplantsOrgan RejectionNCT05215288Direct Biologics, LLC
