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临床试验/EUCTR2007-004322-24-BG
EUCTR2007-004322-24-BG进行中（未招募）不适用

Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.

Ovation Pharmaceuticals Inc.0 个研究点目标入组 240 人开始时间: 2008年11月3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

  • •1. The patient or patient?s legally authorized representative (LAR) must sign and date the
  • •Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
  • •Informed Consent Form (ICF)/Health Insurance Portability and Accountability Act
  • •(HIPAA) Authorization (if required) prior to study participation. If appropriate, the
  • •patient will sign an Assent Form.
  • •2. Male or female patients between 2 and 60 years of age (inclusive).
  • •3. Patient must have been <11 years of age at the onset of LGS.
  • •4. Patient must weigh ≥12.5 kg.
  • •5. If female:
  • •a. Patient is either not of childbearing potential, defined as premenarchal,
  • •postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation,
  • •bilateral oophorectomy or hysterectomy), or if of childbearing potential, must
  • •comply with a method of birth control acceptable to the investigator during the
  • •study, for at least 30 days prior to randomization and for 30 days following
  • •completion of the study.
  • •b. Patient is not breastfeeding.
  • •c. Patients of childbearing potential must have a negative serum pregnancy test at
  • •screening and a negative urine pregnancy test performed on Study Day -1.
  • •6. Patients with LGS as evidenced by:
  • •a. Greater than 1 type of generalized seizures, including drop seizures (atonic, tonic or
  • •myoclonic) for at least 6 months.
  • •b. Written documentation of having met the electroencephalogram (EEG) diagnostic
  • •criteria for a diagnosis of LGS at some point in their history (must have abnormal
  • •background activity accompanied by slow spike and wave pattern <2.5 Hz).
  • •7. Patient must have experienced ≥2 drop seizures per week during the 4-week baseline
  • •8. Patient must be on at least 1 AED. Patient must be on a stable AED dosing regimen for
  • •at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the
  • •ketogenic diet will count as an AED.
  • •9. Patients must not have been on any benzodiazepines chronically (for any indication) for
  • •a period of at least 30 days prior to screening. Patients will be allowed to enter the study
  • •if they have used benzodiazepines as a rescue therapy within the 30 days prior to
  • •screening with a limit of 1 rescue per day up to an average of once per week.
  • •10. In the investigator?s opinion, parent or caregiver must be able to keep an accurate
  • •seizure diary.
  • •11. In the investigator?s and parent/caregiver?s opinions, the patient is able to take study
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1. Etiology of patient?s seizures is a progressive neurologic disease. Patients with tuberous
  • •sclerosis will not be excluded from study participation, unless there is a progressive
  • •2. Patient has had an episode of status epilepticus within 12 weeks of baseline.
  • •3. Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
  • •4. Patient has a clinically significant history of an allergic reaction or significant sensitivity
  • •to benzodiazepines or to any of the other ingredients in clobazam tablets.
  • •5. Patient is taking more than 3 concurrent AEDs. NOTE: VNS or ketogenic diet is
  • •allowed and will not be counted in the three allowed AEDs.
  • •6. Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers
  • •from frequent stooling.
  • •7. If the patient has a VNS, the settings have not been stable for at least 30 days prior to
  • •8. Patient has previously been treated with CLB.
  • •9. Patient has taken corticotropins in the 6 months prior to screening.
  • •10. Patient is currently taking long-term systemic steroids (excluding inhaled medication for
  • •asthma treatment) or any other daily medication known to exacerbate epilepsy. An
  • •exception will be made of prophylactic medication, for example, for idiopathic nephrotic
  • •syndrome or asthma.
  • •11. If the patient is taking felbamate, he/she has been taking it for less than 1 year prior to
  • •12. Patient has experienced a clinically significant unresolved idiosyncratic reaction to an
  • •AED, e.g., topiramate with resulting metabolic acidosis, felbamate with resulting
  • •aplastic anemia or hepatic failure, or lamotrigine with resulting skin irritation and/or
  • •13. Patient has shown any clinically significant history of hyper-sensitivity to central
  • •nervous system (CNS)-active medications leading to neurobehavioral aberrations (e.g.,
  • •increased biting, scratching, kicking or hitting).
  • •14. If the patient is on any chronic medication, the dose has not been stable for at least 30
  • •days prior to screening.
  • •15. Patient has taken or used any investigational drug or device in the 30 days prior to
  • •16. Patient has a clinically significant unstable hepatic, hematological, renal, cardiovascular,
  • •gastrointestinal, or pulmonary disease or ongoing malignancy.
  • •17. Patient has a diagnosis of sleep apnea.
  • •18. Patient has compromised respiratory function or severe respiratory insufficiency.
  • •19. Patient has a clinically significant abnormal laboratory value.
  • •20. Patient has familial long QT syndrome, QT/QTc >500msec or a history of polymorphic
  • •ventricular tachycardia.
  • •21. Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI)
  • •or computed tomography (CT) scan.
  • •22. Patient has a history of drug or alcohol abuse.
  • •23. Patient has a history of poor compliance on past antiepileptic therapy.
  • •24. Patient has inadequate supervision by parent or guardian.
  • •25. For any reason, the patient is considered by the investigator to be an unsuitable
  • •candidate for the study.
  • •26. Patient has a history of severe muscle weakness, including myasthenia gravis.

研究者

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