drugset / Trial / NCT02256124
Effect of Lamotrigine on Cognition in NF1
Phase 2/3
Terminated
41 enrolled
Erasmus Medical Center
Hospital Sant Joan de Deu · collabUniversitaire Ziekenhuizen KU Leuven · collabZonMw: The Netherlands Organisation for Health Research and Development · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.
Timeline
- Start
- 2014-10
- Primary completion
- 2020-04
- Completion
- 2020-04
Publications
- Ottenhoff MJ, Heuvelmans A, Castricum J, Tulen JH, Rens G, Fujiyama H, Levin O, Swinnen SP, Moll HA, Wit MY, Elgersma Y. The effect of lamotrigine on cortical inhibition and plasticity in Neurofibromatosis type 1: Exploratory analysis of a randomized controlled trial (NF1-EXCEL). Clin Neurophysiol. 2025 May;173:150-162. doi: 10.1016/j.clinph.2025.02.270. Epub 2025 Mar 10.
- Ottenhoff MJ, Mous SE, Castricum J, Rietman AB, Oostenbrink R, van der Vaart T, Tulen JHM, Parra A, Ramos FJ, Legius E, Moll HA, Elgersma Y, de Wit MY; ENCORE Expertise Center for NF1. Lamotrigine for cognitive deficits associated with neurofibromatosis type 1: A phase II randomized placebo-controlled trial. Dev Med Child Neurol. 2025 Apr;67(4):537-549. doi: 10.1111/dmcn.16094. Epub 2024 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamotrigine | Small molecule | 100 mg | Oral |