EUCTR2014-002321-35-IT进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With anOpen-Label Extension Phase of Perampanel as Adjunctive Treatment inSubjects at Least 2 years of Age With Inadequately Controlled SeizuresAssociated With Lennox-Gastaut Syndrome -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 142
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 meet all of the following criteria to be included in this
- •1. Subjects must have diagnosis of LGS as evidenced by:
- •a. More than one type of generalized seizures, including drop seizures
- •(atonic, tonic, or myoclonic) for at least 6 months before Visit 1
- •b. An EEG reporting diagnostic criteria for LGS at some point in their
- •history (abnormal background activity accompanied by slow, spike and wave pattern <2.5 Hz)
- •2. Subjects must be at least 2 years old at the time of consent.
- •3. Subjects must have been <11 years old at the onset of LGS.
- •4. Subjects must have experienced at least 2 drop seizures per week in
- •the 4 -week Baseline Period preceding randomization; the Baseline
- •Period within the Prerandomization Phase is 4 weeks.
- •5. Subjects must have been receiving 1 to 3 concomitant AEDs at a
- •stable dose for at least 30 days before Visit 1 (vagal nerve stimulation
- •[VNS] and ketogenic diet do not count as an AED).
- •6. In the investigator's opinion, parents or caregivers must be able to
- •keep accurate seizure diaries.
- •7. Body weight at least 8 kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Presence of progressive neurological disease
- •2. Presence of drop seizure clusters where individual seizures cannot be
- •reliably counted
- •3. Prior treatment with perampanel with discontinuation due to safety
- •issues (related to perampanel)
- •4. Prior treatment with perampanel must have been discontinued at
- •least 30 days before Visit 1
- •5. Evidence of clinically significant disease (eg, cardiac, respiratory,
- •gastrointestinal, renal disease, hepatic disease) that in the opinion of
- •the investigator(s) could affect the subject's safety or study conduct
- •6. Scheduled for epilepsy-related surgery or any other form of surgery
- •during the projected course of the study
- •7. Ketogenic diet and VNS, unless stable and ongoing for at least 30 days
- •before Visit 1
- •8. Treatment with an investigational drug or device in the 30 days before
- •9. Status epilepticus within 12 weeks of Visit 1
- •10. If felbamate is used as a concomitant AED, subjects must be on
- •felbamate for at least one year, with a stable dose for 60 days before
- •Visit 1. They must not have an indication of hepatic or bone marrow
- •dysfunction while receiving felbamate.
- •11. Concomitant use of vigabatrin: Subjects who took vigabatrin in the
- •past must be discontinued for at least 5 months before Visit 1, and must
- •have documentation showing no evidence of a vigabatrin-associated
- •clinically significant abnormality in an automated visual perimetry test
- •12. Have had multiple drug allergies or a severe drug reaction to an
- •AED(s), including dermatological (eg, Stevens-Johnson syndrome),
- •hematological, or organ toxicity reactions
- •13. Evidence of significant active hepatic disease. Stable elevations of
- •liver enzymes, alanine aminotransferase (ALT), and aspartate
- •aminotransferase (AST) due to concomitant medication(s) will be
- •allowed if they are < 3 times the ULN
- •14. Adrenocorticotropic hormone within the 6 months before Visit 1
- •15. Had history of anoxic episodes requiring resuscitation within 6
- •months before Visit 1
- •16. Females who are breastfeeding or pregnant at Screening or Baseline.
- •A separate baseline assessment is required if a negative screening
- •pregnancy test was obtained more than 72 hours before the first dose of
- •study drug.
- •17. Females of childbearing potential who:
- •Within 28 days before study entry, did not use a highly effective method
- •of contraception, which includes any of the following:
- •o Total abstinence
- •o An intrauterine device or intrauterine hormone-releasing system (IUS)
- •o An oral contraceptive
- •o Have a vasectomized partner with confirmed azoospermia.
- •Do not agree to use a highly effective method of contraception (as
- •described above) throughout the entire study period and for 28 days
- •after study drug discontinuation.
- •18. Had intermittent use of benzodiazepine of more than 4 single
- •administrations in the month before Visit 1
- 另有 13 项未显示
研究者
相似试验
进行中（未招募）
不适用
Study of the Safety and Efficacy of BOTOX® in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.EUCTR2009-013088-20-PLAllergan Ltd534
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® as Applicable in Patients with Idiopathic Overactive Bladder with Urinary IncontinencePatients with symptoms of idiopathic overactive bladder (frequency and urgency) and urinary incontinence, whose symptoms have not been adequately managed with anticholinergic therapyMedDRA version: 12.0Level: LLTClassification code 10059617Term: Overactive bladderEUCTR2009-013088-20-NLAllergan Ltd534
进行中（未招募）
1 期
A clinical trial to investigate the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Gastroparesisdiabetic or idiopathic gastroparesis.MedDRA version: 19.0Level: LLTClassification code 10021227Term: Idiopathic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 19.0Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2014-003250-13-PLTheravance Biopharma R&D, Inc.200
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivityrinary incontinence due to neurogenic detrusor overactivityMedDRA version: 9.1Level: LLTClassification code 10029279Term: Neurogenic bladderEUCTR2007-000192-42-NLAllergan Ltd260
已完成
不适用
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)-B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24PER-173-08MERCK SHARP & DOHME PERU S.R.L.,