NCT06534502尚未招募4 期
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg/5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures
Azurity Pharmaceuticals4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Concentration of serum zonisamide
研究概览
简要总结
The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria:
- •Voluntarily obtained informed consent from parent/legal guardian of the participant and assent from the participant, when appropriate.
- •Willing and able to follow protocol specific requirements.
- •Participant of 1 month to 17 years of age, inclusive (at time of consent).
- •Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against Epilepsy (ILAE) classification of seizures. Participants with both focal-onset and generalized-onset seizures are eligible, but only focal-onset seizures count toward baseline seizure enrollment criteria. Tonic-clonic and tonic seizures with unknown onset are presumed to be focal-onset unless there are clear clinical and EEG data suggesting generalized-onset.
- •Participant with seizure occurrence more than once in the past three (3) months and more than two (2) times in the past six (6) months.
- •a. Participant who is 6 months of age and younger will have seizure profiling patterns assessed by the Investigator for appropriate consideration and inclusion in the study.
- •Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening
- •a. Participant who is 6 months of age and younger will have regimen assessed for inclusion in the study at Investigator's discretion.
- •Participant with acceptable laboratory investigations:
- •Hemoglobin within normal range
- •Alanine aminotransferase (ALT) within normal range
- •Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN)
- •Bilirubin within normal range
- •Creatinine clearance within normal range
- •If male participant is able to father children must be willing to use a highly effective method of contraception for at least one month after the last dose of investigational product if at risk of pregnancy with her/his partner. If female participant has reached menarche, the participant is authorized to participate in this clinical study if additional criteria are met.
- •At screening:
- •(i) Participant reports sexual abstinence for the prior 3 months or reports use of at least 1 of the acceptable methods of contraception, including an intrauterine device, barrier methods (e.g., male or female condom), hormonal contraceptives (e.g., hormonal patches, vaginal devices, oral pills), levonorgestrel intrauterine system (e.g., Mirena®), or regular medroxyprogesterone injections (e.g., Depo-Provera®); or (ii) Participant agrees to initiate sexual abstinence from the time of screening until at least one month after end of treatment with study drug; and
- •Participant is advised to avoid conception from the time of screening until at least one month after last receipt of study drug and agrees not to attempt pregnancy from the time of screening until at least one month after end of treatment with study drug; and
- •Participant is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and
- •Participant has a negative serum β-human chorionic gonadotropin (β-hCG) test just prior to study entry. Since serum tests may miss an early pregnancy, relevant menstrual history and sexual history, including methods of contraception, should be considered. Note: if the result of the serum β-hCG test cannot be obtained prior to dosing of investigational product, a participant may be enrolled on the basis of a negative urine pregnancy test, though a serum β-hCG test result must still be obtained.
排除标准
- •Pediatric participant will be excluded from the study based on the following criteria:
- •Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.
- •Participant who is pregnant or nursing.
- •Participant with exclusively generalized-onset seizures.
- •Participant with predisposition to nephrolithiasis or prior history of kidney stone(s).
- •Participant who is underweight (weight-for-age <2 standard deviation (SD) from the median of the World Health Organization (WHO) Child Growth Standards) or have a decreased appetite.
- •Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide.
- •Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction.
- •Participant who has previously received zonisamide.
- •Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Participant who has degenerative or metabolic disease of the brain.
- •Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment).
- •Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study.
- •Participant who has participated in other clinical study 30 days prior to enrollment in this study or 4-5 half lives of investigational drug, whichever is longer.
- •Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants.
- •Participant has a positive COVID-19 polymerase chain reaction (PCR) test result; or has had exposure (within 2 weeks prior to screening) to someone who had a positive COVID-19 test result; or is suspected of having long COVID-19 by the Investigator or designee.
- •Participant who is missing more than 15% of daily diary entries during the screening period.
研究组 & 干预措施
Zonisamide Oral Suspension
Experimental
Zonisamide Oral Suspension, 100 mg/5 ml administered orally twice daily
- Titration Period: 1 mg/kg/day administered as a divided dose of 0.5 mg/kg twice daily for 2 weeks, then increased by 1 mg/kg/day (as divided doses) at weekly intervals in Weeks 3 to 8.
- Maintenance Period: Up to 8 mg/kg/day given as a divided dose twice a day for 4 weeks (i.e., Weeks 9 to 12).
干预措施: Zonisamide Oral Product (Drug)
结局指标
主要结局
Concentration of serum zonisamide
时间窗: Up to 15 weeks
The concentration in serum of zonisamide following administration of zonisamide oral suspension, 100 mg/5 ml
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)(Up to 15 weeks)
- Number and/or percentage of participants who discontinued the study because of adverse events(Up to 15 weeks)
- Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.(Up to 15 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.Partial, Generalized and Combined SeizuresNCT01283256Eisai Inc.655
已完成
3 期
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized SeizuresEpilepsyNCT00292461Eisai Inc.64
已完成
3 期
A Study of Zonisamide to Prevent Olanzapine-Associated Weight GainWeight GainNCT00363376Lindner Center of HOPE42
已完成
不适用
Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy SubjectsMultiple SclerosisUlcerative ColitisNCT06528665Corium Innovations, Inc.24
终止
3 期
Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised EpilepsyEpilepsyNCT00693017Eisai Limited10