EUCTR2013-003405-26-BE进行中（未招募）不适用
The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 60
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
- •NF1 patients with a genetically confirmed diagnosis
- •Age 12-17.5 years at inclusion
- •Oral and written informed consent by parents and assent from
- •participants
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •Segmental NF1
- •Hearing problems or deafness
- •Use of the following medication: fenytoïn, carbamazepine,
- •fenobarbital, primidon, rifampicine, atazanavir/ritonavir,
- •lopinavir/ritonavir, oxcarbazepine, topiramate, oral contraceptive pill (with stopweek, containing both oestrogen and progestagen) and valproic acid during the last 3 months.
- •Previous use of lamotrigine
- •Previous allergic reactions to anti-epileptic drugs
- •Epilepsy or epilepsy in the past
- •Suicidal thoughts or behaviour
- •Renal insufficiency
- •Liver insufficiency
- •Pregnancy
- •Brain tumour or other brain pathology potentially influencing the outcome measures
研究者
相似试验
已完成
2 期
The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL)Neurofibromatosis type 1Von Recklinghausen disease1002929910009841NL-OMON47363Erasmus MC, Universitair Medisch Centrum Rotterdam30
进行中（未招募）
1 期
Treating learning disabilities in Neurofibromatosis 1 using lamotrigineEUCTR2013-003405-26-DKErasmus MC60
进行中（未招募）
1 期
Treating learning disabilities in Neurofibromatosis 1 using lamotrigineEUCTR2013-003405-26-ESErasmus MC60
进行中（未招募）
不适用
Treating learning disabilities in Neurofibromatosis 1 using lamotrigineeurofibromatosis type 1MedDRA version: 17.0Level: LLTClassification code 10029270Term: Neurofibromatosis, type 1 (von Recklinghausen's disease)System Organ Class: 100000004850EUCTR2013-003405-26-NLErasmus MC60
终止
2 期
Effect of Lamotrigine on Cognition in NF1Neurofibromatosis Type 1NCT02256124Erasmus Medical Center41