Treating learning disabilities in Neurofibromatosis 1 using lamotrigine
- Conditions
- eurofibromatosis type 1MedDRA version: 17.1Level: LLTClassification code 10029270Term: Neurofibromatosis, type 1 (von Recklinghausen's disease)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2013-003405-26-BE
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method