Treating learning disabilities in Neurofibromatosis 1 using lamotrigine

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003405-26-NL

Enrollment

Registered

2013-09-20

Start date

2014-09-03

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis type 1 MedDRA version: 17.0 Level: LLT Classification code 10029270 Term: Neurofibromatosis, type 1 (von Recklinghausen's disease) System Organ Class: 100000004850

Interventions

Trade Name: Lamotrigine dispers Pharmaceutical Form: Dispersible tablet INN or Proposed INN: Lamotrigine Other descriptive name: LAMOTRIGINE Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion 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 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

Exclusion criteria: • Segmental NF1 • Severe visual problems or blindness • Severe hearing problems or deafness • Use of the following medication: fenytoïn, carbamazepine, fenobarbital, primidon, rifampicine, atazanavir/ritonavir, lopinavir/ritonavir, oxcarbazepine, topiramate, oral contraceptive pill (containing oestrogen and progestagen and in case a stop week is implemented) 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

Design outcomes

Primary

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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

Measure	Time frame
Secondary end point(s): Visual spatial learning efficacy - Paired Associate Learning (from the CANTAB, Cambridge Neuropsychological Test Automated Battery) Visual perception - Motor-free Visual Perception Test (MVPT) Sustained attention - SA-DOTS (from the ANT, Amsterdam Neuropsychological Tasks) Fine motor coordination - Grooved Pegboard Test Visual-motor intetration - Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery-VMI) Attention problems - Parent reported ADHD-questionnaire (AVL, ADHD Vragenlijst) Executive functioning - Parent reported Behavior Rating Inventory of Executive Functioning (BRIEF) Intracortical inhibition - Short-interval Intracortical Inhibition (SICI), measured by paired pulse stimulation Cortical plasticity - LTP-like plasticity, measured by paired associative stimulation (PAS);Timepoint(s) of evaluation of this end point: Baseline and 26 weeks of treatment for neuropsychological tests and questionnaires. Baseline and after 10 weeks for neurophysiological outcome measures.	—

Measure

Time frame

Secondary end point(s): Visual spatial learning efficacy - Paired Associate Learning (from the CANTAB, Cambridge Neuropsychological Test Automated Battery) Visual perception - Motor-free Visual Perception Test (MVPT) Sustained attention - SA-DOTS (from the ANT, Amsterdam Neuropsychological Tasks) Fine motor coordination - Grooved Pegboard Test Visual-motor intetration - Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery-VMI) Attention problems - Parent reported ADHD-questionnaire (AVL, ADHD Vragenlijst) Executive functioning - Parent reported Behavior Rating Inventory of Executive Functioning (BRIEF) Intracortical inhibition - Short-interval Intracortical Inhibition (SICI), measured by paired pulse stimulation Cortical plasticity - LTP-like plasticity, measured by paired associative stimulation (PAS);Timepoint(s) of evaluation of this end point: Baseline and 26 weeks of treatment for neuropsychological tests and questionnaires. Baseline and after 10 weeks for neurophysiological outcome measures.

—

Countries

Netherlands

Contacts

Public ContactENCORE - NF1 Expertise centre

Erasmus MC

nf1centrum@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026