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Effect of Lamotrigine on Cognition in NF1

Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurofibromatosis Type 1

Intervention: Lamotrigine (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
Ype Elgersma, PhD, Principal Investigator, Affiliation: Erasmus Medical Center
Henriette A Moll, MD, PhD, Principal Investigator, Affiliation: Erasmus Medical Center

Overall contact:
Marie-Claire Y de Wit, MD, PhD, Phone: +31107036956, Email: m.c.y.dewit@erasmusmc.nl

Summary

The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.

Clinical Details

Official title: The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Performance intelligence quotient (change from baseline)

Secondary outcome:

Visual-spatial working memory (change from baseline)

Visual perception (change from baseline)

Sustained attention (change from baseline)

Visual-motor integration (change from baseline)

Fine motor coordination (change from baseline)

Attention problems (change from baseline)

Executive functioning (change from baseline)

Short intracortical inhibition (SICI) (change from baseline)

Long-term potentiation-like plasticity (change from baseline)

Detailed description: Cognitive deficits in the autosomal dominant disorder Neurofibromatosis type 1 (NF1) typically consist of a lower than average IQ, impaired visual-spatial learning, attention problems and impaired executive functioning. These deficits have a substantial influence on the daily life of pediatric and adolescent individuals with NF1. One of the key underlying mechanisms of these deficits is an increased gamma-aminobutyric acid (GABA)-ergic inhibition and a subsequent decrease in synaptic plasticity. The ENCORE laboratory has recently shown that loss of the NF1-gene is associated with attenuated function of the hyperpolarization-activated cyclic nucleotide-gated channel 1 (HCN1). These channels, enriched in membranes of inhibitory interneurons, play an important role in the pathophysiology underlying the cognitive deficits in NF1. Lamotrigine, an HCN-agonist, restored function of HCN1, together with the electrophysiological and visual-spatial learning deficits in Nf1-mice. Thus, lamotrigine is a novel candidate drug for treating cognitive deficits associated with NF1.

Eligibility

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): Both.

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

Exclusion Criteria:

- Segmental NF1

- Severe hearing problems or deafness

- Severe visual problems or blindness

- Use of the following medication, as of interaction with lamotrigine: phenytoin,

carbamazepine, phenobarbital, primidon, rifampicin, atazanavir/ritonavir, lopinavir/ritonavir, oxcarbazepine, topiramate, oral contraceptive pill including stop-week (estrogen and progesterone) and valproic acid during 3 months before inclusion.

- Use of psycho-active medication other than methylphenidate

- 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

Locations and Contacts

Marie-Claire Y de Wit, MD, PhD, Phone: +31107036956, Email: m.c.y.dewit@erasmusmc.nl

University Hospital Leuven, Leuven B-3000, Belgium; Not yet recruiting
Eric Legius, MD, PhD, Phone: +3216345903, Email: eric.legius@uzleuven.be
Ellen Plasschaert, MSc, Phone: +3216345903, Email: ellen.plasschaert@uzleuven.be
Ellen Plasschaert, MSc, Sub-Investigator
Eric Legius, MD, PhD, Principal Investigator

Erasmus Medical Center, Rotterdam, South Holland 3015CN, Netherlands; Recruiting
Marie-Claire Y de Wit, MD, PhD, Principal Investigator
Myrthe Ottenhoff, MD, MSc, Sub-Investigator

Additional Information

ENCORE expertise center

Starting date: October 2014
Last updated: August 3, 2015

Page last updated: August 23, 2015

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