Treating learning disabilities in Neurofibromatosis 1 using lamotrigine

• Conditions: eurofibromatosis type 1; MedDRA version: 17.0Level: 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-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-20
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.