Clinical trial · Interventional
Effect of Lamotrigine on Cognition in NF1
The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL)
NCT02256124CI-TRIAL-00044629NF1-EXCELterminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to our experience, the small number of new inclusions, and the uncertainty regarding the COVID-19 outbreak, we have decided to discontinue the study.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether lamotrigine can improve cognitive and neurophysiological deficits in adolescents with Neurofibromatosis type 1.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lamotrigine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lamotrigine
- description
- Lamotrigine during 28 consecutive weeks: * 8 weeks dose-increase phase: from 25mg once daily to 100mg twice daily * 18 weeks target-dose phase: 100mg twice daily * 2 weeks decline-phase: 100mg once daily.
- interventionNames
- Drug: Lamotrigine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo tablets during 28 consecutive weeks, with identical appearance to lamotrigine tablets, mimicking the lamotrigine dosing schedule.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Performance intelligence quotient (change from baseline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDOttenhoff 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. PMID 40121838
- DERIVEDOttenhoff 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. PMID 39340758