Treating learning disabilities in Neurofibromatosis 1 using lamotrigine

Phase 1

• Conditions: eurofibromatosis type 1; MedDRA version: 20.0Level: LLTClassification code 10029270Term: Neurofibromatosis, type 1 (von Recklinghausen's disease)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-003405-26-DK
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-24
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Exclusion Criteria

•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 (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
Main Objective: The objective of this proposal is to find proof-of-principle for an effect of Lamotrigine on cognitive functioning in adolescents with Neurofibromatosis type 1. ;Secondary Objective: Secondary objectives are the evaluation of the safety and the effect of lamotrigine on subdomains of cognitive function, intra-cortical inhibition and LTP-like plasticity.;Primary end point(s): Performal IQ (WISC-III);Timepoint(s) of evaluation of this end point: Baseline and after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Visual spatial learning efficacy<br>-Paired Associate Learning (from the CANTAB, Cambridge Neuropsychological Test Automated Battery)<br>Auditory attention<br>-Score! (from the TEACH, Test of Everyday Attention in Children)<br>Fine motor coordination<br>-Grooved Pegboard Test<br>Attention problems<br>-Parent reported ADHD-questionnaire (AVL, ADHD Vragenlijst)<br>Intracortical inhibition<br>-Short-interval Intracortical Inhibition (SICI), measured by paired pulse stimulation<br>Cortical plasticity<br>-LTP-like plasticity, measured by paired associative stimulation (PAS)<br>;Timepoint(s) of evaluation of this end point: Baseline and 26 weeks of treatment.