NL-OMON47363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) - NF1-EXCEL Effect of lamotrigine on cognition in NF1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
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
排除标准
- •* Segmental NF1
- •* Severe hearing problems or deafness
- •* Severe visual problems or blindness
- •* Use of the following medication: fenytoïn, carbamazepine, fenobarbital, primidon, rifampicine, atazanavir/ritonavir, lopinavir/ritonavir, oxcarbazepine, topiramate, oral contraceptive pill (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
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终止
2 期
Effect of Lamotrigine on Cognition in NF1Neurofibromatosis Type 1NCT02256124Erasmus Medical Center41