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: 100000012614; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Last Update Posted: 23 October 2017

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
-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