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临床试验/EUCTR2005-001338-33-CZ
EUCTR2005-001338-33-CZ进行中（未招募）不适用

A Randomized, Double-Blind, Placebo Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age, Inclusive) With Refractory Partial-Onset Seizures, With Open-Label Extension - Topiramate Infant Partial Onset Epilepsy

Janssen-Cilag International N.V.0 个研究点目标入组 240 人开始时间: 2005年6月21日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
240
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Subjects must be male or female infants between 1 and 24 months of age,
  • •inclusive, at screening.
  • •Subjects must be at least 41 weeks of gestational age at screening.
  • •Subjects must be receiving regular enteral feeding (solid food; bottle- or
  • •cup-fed; or using gastrostomy, jejunostomy, or nasogastric tube), with or
  • •without breast-feeding.
  • •Subjects must weigh =3.5 kg and <15.5 kg at screening; length using an
  • •infant measuring table (heel to crown) must be =49 cm. There must be
  • •evidence of continued weight and height gain prior to the first day of
  • •Parents (or their legally-acceptable representatives) of subjects must have
  • •signed an informed consent/permission document indicating that they
  • •understand the purpose of and procedures required for the study and are
  • •willing to give permission for their child to participate in the study.
  • •Subjects must have clinical or EEG evidence of POS (simple or complex),
  • •with or without secondary generalization, at least 1 month prior to the first
  • •day of screening in subjects >6 months of age, or at least 2 weeks prior to the
  • •first day of screening in subjects =6 months of age. Subjects may have
  • •multiple seizure types as long as POS is present. Acceptable evidence of POS
  • •includes 1 of the following:
  • •– Documented recurrent clinical seizures with asymmetric motor features or
  • •characteristic behavioral alterations. The interictal EEGs may be negative
  • •or inconclusive, provided that the clinical criterion for POS is met.
  • •– A routine EEG or vEEG showing focal or asymmetric EEG findings
  • •(epileptiform discharges, focal slowing, focal attenuation, or a
  • •combination), with or without secondary generalization. Clinical seizures
  • •with symmetric or behavioral features are acceptable in the presence of
  • •EEG evidence of an asymmetric origin.
  • •Subjects must have been receiving at least 1 concurrent marketed AED for
  • •=1 month for subjects >6 months of age and for >2 weeks for subjects
  • •=6 months of age; for subjects entering the double-blind treatment phase, this
  • •regimen must remain unchanged throughout the screening and double-blind
  • •treatment phases with the exception of dosage reduction for non-study AEDs
  • •because of elevated AED levels or side effects, made at the discretion of the
  • •investigator.
  • •As documented on the worksheet for inadequacy of current epilepsy
  • •treatment, the regimen of AEDs at entry:
  • •– Must be considered to be optimized (including, if clinically appropriate,
  • •recent demonstration of adequate blood levels) in the opinion of the
  • •investigator
  • •– Must be considered inadequate in controlling seizures in the opinion of the
  • •investigator, as shown in part by a retrospective history of at least
  • •1 seizure in the 4 weeks prior to the first day of screening
  • •– For subjects entering the double-blind treatment phase, must have been
  • •unchanged for at least 5 half-lives prior to the first day of screening, as
  • •described in Section 8.1 and Attachment 2
  • •Caregivers (parents or their legally-acceptable representatives) of the subjects
  • •must be able to accurately maintain the subject take-home record, including
  • •items of general health.
  • •Subjects must have had a computed tomography (CT) or magnetic resonance
  • •imaging (MRI) scan to confirm the absence of a progressive lesion, such as a
  • 另有 4 项未显示

排除标准

  • •Infants who are exclusively breast-fed and cannot take oral liquid medication
  • •Subjects with a surgically implanted and functioning vagus nerve stimulator
  • •Subjects with a history of febrile seizures or seizures due to an acute medical
  • •illness within 2 weeks prior to the first day of screening
  • •Subjects with a history of infantile seizures as a result of a correctable
  • •medical condition, such as metabolic disturbance, toxic exposure, neoplasm,
  • •or active infection within 2 weeks prior to the first day of screening
  • •Subjects with a history of nonepileptic seizures within 2 weeks prior to the
  • •first day of screening
  • •Subjects who have had epilepsy surgery within 3 months prior to the first day
  • •of screening
  • •Subjects with any progressive neurologic disorder, including malignancy,
  • •brain tumor, active central nervous system infection, demyelinating disease,
  • •or degenerative or progressive central nervous system disease, with the
  • •exception of tuberous sclerosis and Sturge Weber syndrome
  • •Subjects with any clinically significant uncontrolled medical illness,
  • •including hepatic or renal failure, ischemic cardiac disease, malignancy, or
  • •any disorder that, in the opinion of the investigator, places the subject at risk
  • •through participation in a clinical study
  • •Subjects with nephrocalcinosis, renal stones of any type, or hydronephrosis,
  • •as evidenced by medical history or screening examination
  • •Subjects with congenital glaucoma, abnormal slit-lamp examination
  • •(if previously performed), or known ocular deficits, or subjects receiving any
  • •ocular medications except lubricating eye drops or topical antibiotics
  • •Subjects with a known history of central hyperthermia, dysautonomia, or
  • •other disturbances of autonomic function
  • •Subjects with a known history of inborn errors of metabolism, mitochondrial
  • •dysfunction, or prior evidence of hyperammonemia
  • •Subjects with any clinically significant abnormality in laboratory tests at
  • •screening, including but not limited to:
  • •– White blood cell (WBC) count <3,000/mL or absolute neutrophil count
  • •<1,000 /mL in the last 6 months for infants >6 months of age or at any
  • •time for those =6 months of age
  • •– AST or ALT, =2 times the ULN
  • •– Total bilirubin =1.5 mg/dL or conjugated bilirubin =0.6 mg/dL
  • •– Venous ammonia =2 times the ULN
  • •– Creatinine clearance <70 mL/min per 1.73 m3 for infants =1 month to
  • •<6 months of age or <90 mL/min per 1.73 m3 for infants =6 months to
  • •<2 years of age; creatinine clearance at screening should be estimated
  • •using the Schwartz formula
  • •Subjects who have CO2 levels <18 mmol/L, have a diagnosis of metabolic
  • •acidosis, or are on alkali therapy
  • •Subjects being treated with furosemide, hydrochlorothiazide, vigabatrin,
  • •injectable vitamin B6 therapy for pyridoxine-dependent epilepsy, monoamine
  • •oxidase (A or B) inhibitors, felbamate, zonisamide, or any other medication
  • •that is a potent carbonic anhydrase inhibitor (e.g., acetazolamide). Past
  • •treatment with furosemide for more than 2 weeks must be discussed with the
  • •Subjects who have been treated with an investigational drug within 2 weeks
  • •prior to the first day of screening
  • •Subjects who have previously used topiramate or who have participated in a
  • 另有 5 项未显示

研究者

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