Effect of Lamotrigine on Cognition in NF1

• Status: Terminated
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Hospital Sant Joan de Deu; Universitaire Ziekenhuizen Leuven; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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