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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02256124 |
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Date of registration:
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17/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Lamotrigine on Cognition in NF1
NF1-EXCEL |
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Scientific title:
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The Effect of Lamotrigine on Cognitive Deficits Associated With Neurofibromatosis Type 1: a Phase II Randomized Controlled Multi-centre Trial (NF1-EXCEL) |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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41 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02256124 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Belgium
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Netherlands
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Spain
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Contacts
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Name:
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Ype Elgersma, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus Medical Center |
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Name:
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Henriette A Moll, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neurofibromatosis Type 1
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Intervention(s)
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Drug: Lamotrigine
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Drug: Placebo
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Primary Outcome(s)
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Performance intelligence quotient (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Secondary Outcome(s)
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Visual-motor integration (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Attention problems (change from baseline)
[Time Frame: Baseline, 10 weeks, 26 weeks and 52 weeks]
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Visual perception (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Visual-spatial working memory (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Long-term potentiation-like plasticity (change from baseline)
[Time Frame: Baseline and 10 weeks]
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Fine motor coordination (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Short intracortical inhibition (SICI) (change from baseline)
[Time Frame: Baseline and 10 weeks]
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Executive functioning (change from baseline)
[Time Frame: Baseline, 26 weeks and 52 weeks]
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Sustained attention (change from baseline)
[Time Frame: Baseline and 26 weeks]
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Secondary ID(s)
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113303003
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MEC-2013-460
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2013-003405-26
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NL 44912.078.13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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