The effect of Lamotrigine on cognitive deficits associated with Neurofibromatosis type 1: a phase II randomized controlled multi-centre trial (NF1-EXCEL)

Phase 2

Completed

Conditions: Neurofibromatosis type 1
Von Recklinghausen disease
10029299
10009841

Registration Number: NL-OMON47363

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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: 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cognitive functioning<br /><br>- Performal intelligence (Wechsler Scales for Intelligence: 12 * 16 yrs:<br /><br>WISC-III-NL; 17-18 yrs: WAIS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Visual spatial learning efficacy<br /><br>- Paired Associate Learning (from the CANTAB, Cambridge Neuropsychological Test<br /><br>Automated Battery)<br /><br>Attention<br /><br>- Sustained Attention Dots (SADOTS, from the ANT, Amsterdam Neuropsychological<br /><br>Tasks)<br /><br>Fine motor coordination<br /><br>- Grooved Pegboard Test<br /><br>- Beery Visual Motor Intergration/ motor coordination task (Beery-VMI-6)<br /><br>Attention problems<br /><br>- Parent reported ADHD-questionnaire (AVL, ADHD Vragenlijst)<br /><br>Executive function<br /><br>- Behavior Rating Inventory of Executive Function (BRIEF-questionnaire)<br /><br>Intracortical inhibition<br /><br>- Short-interval Intracortical Inhibition (SICI), measured by paired pulse<br /><br>stimulation<br /><br>Cortical plasticity<br /><br>- LTP-like plasticity, measured by paired associative stimulation (PAS)</p><br>