CTIS2023-506301-20-00招募中1 期
A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II. - RAD-GRIN-201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Age range: = 6 months up to 18 years at Part A Baseline, Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriate dosages and durations, Disease specific criteria: a. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) b. diagnosis of TSC by either clinical or genetic diagnostic criteria (Northrup, 2021) as documented in the participant’s medical record., Participant on average has had at least 8 countable/witnessed primary seizures during a 4 week baseline period with at least 1 seizure occurring in at least 3 of the 4 weeks of Baseline, All medical interventions for epilepsy / behavior (including ketogenic diet and any neurostimulation devices) should be stable for 28 days prior to Screening with no more than 6 days per month use of rescue medication. Participants must remain on a stable regimen throughout the treatment period., Participant’s or their caregivers have signed informed consent and participant has signed assent (if applicable)., Participant’s or their caregivers are willing and able to complete entries in the eDiary on a daily basis., Participant has had an MRI scan within 12 weeks of Screening or during the Screening Period., Participant is 1 of the following: a. Not of childbearing potential (premenarchal or male/not in possession of a uterus). b. If of childbearing potential, is nonpregnant (negative serum pregnancy test results at Screening and negative urine pregnancy test results at Baseline), nonlactating, and practicing 1 of the following medically acceptable methods of birth control: ? Abstinence as a lifestyle choice. ? Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant’s usual menstrual cycle period) before IP administration. ? Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.
排除标准
- •Participant with any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to TSC or FCD Type II that would preclude or jeopardize participant’s safe participation or administration of study drug or the conduct of the study according to the judgement of the Investigator., Participant with any clinically significant laboratory or ECG abnormalities that according to the Investigator in consultation with the Sponsor would jeopardize the safety of the participant, limit participation, or compromise the interpretation of the safety data from the participant., Participant has severe hepatic dysfunction (Child-Pugh grade C)., Participant has a history of brain surgery within 6 months of randomization for epilepsy or any other reason., Participant with any contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances., Participant receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel., Participant has received an investigational treatment within 3 months or 5 half-lives of Screening, whichever is longer.
研究者
相似试验
进行中（未招募）
1 期
Safety, Tolerability and Efficacy of Ceftaroline in Babies with Late-Onset Sepsisate-onset SepsisMedDRA version: 17.1Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 100000004862EUCTR2014-003243-34-ESAstraZeneca AB24
进行中（未招募）
1 期
Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset SepsisEUCTR2014-003243-34-ITASTRAZENECA AB11
进行中（未招募）
1 期
Safety, Tolerability and Efficacy of Ceftaroline in Babies with Late-Onset SepsisEUCTR2014-003243-34-LTPfizer Inc.24
进行中（未招募）
1 期
Safety, Tolerability and Efficacy of Ceftaroline in Babies with Late-Onset Sepsisate-onset SepsisMedDRA version: 20.0Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 100000005053EUCTR2014-003243-34-HUPfizer Inc.24
进行中（未招募）
不适用
Contrast-Enhanced MRI of the supra-aortic vesselsSubjects with known or suspected vascular disease of the supra-aortic vesselsMedDRA version: 16.0Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-023001-36-SEBayer Health Care AG398