Status:
TERMINATED
Effect of Lamotrigine on Cognition in NF1
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Neurofibromatosis Type 1
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.
Detailed Description
Cognitive deficits in the autosomal dominant disorder Neurofibromatosis type 1 (NF1) typically consist of a lower than average IQ, impaired visual-spatial learning, attention problems and impaired exe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Segmental NF1
- Severe hearing problems or deafness
- Severe visual problems or blindness
- Use of the following medication, as of interaction with lamotrigine: phenytoin, carbamazepine, phenobarbital, primidon, rifampicin, atazanavir/ritonavir, lopinavir/ritonavir, oxcarbazepine, topiramate, oral contraceptive pill including stop-week (estrogen and progesterone) and valproic acid during 3 months before inclusion.
- Use of psycho-active medication other than methylphenidate
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02256124
Start Date
October 1 2014
End Date
April 1 2020
Last Update
April 14 2020
Active Locations (3)
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1
University Hospital Leuven
Leuven, Belgium, B-3000
2
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015CN
3
Hospital Sant Joan de Deu
Barcelona, Spain