EUCTR2014-002321-35-PL进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated 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
- 70
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 study:
- •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: 135
- •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 Visit 1
- •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
- •19. A prolonged QT/QTc interval as demonstrated by a repeated electrocardiogram (ECG)
- •20. Hypersensitivity to the study drug or any of the excipients
- •21. Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator(s) would compromise the subject’s ability to safely complete the study
- •22. Known to be human immunodeficiency virus (HIV) positive
- •23. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- •24. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2
研究者
相似试验
进行中（未招募）
1 期
A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2018-002303-33-BECB Biopharma SR625
招募中
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancernon-spread Castration-Resistant Prostate Cancer10036958NL-OMON54510Aragon Pharmaceuticals, Inc.35
进行中（未招募）
1 期
A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseEUCTR2019-002531-29-GBVisterra, Inc.144
进行中（未招募）
不适用
Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary SyndromeType 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS)MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2009-011222-34-SETakeda Development Centre Europe Ltd.5,400
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.Type 2 Diabetes MellitusEUCTR2009-010224-25-HUBristol-Myers Squibb International Corporation152