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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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16 October 2023 |
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Main ID: |
NCT03547050 |
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Date of registration:
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24/05/2018 |
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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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Rolandic Epilepsy Genomewide Association International Study
REGAIN |
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Scientific title:
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Rolandic Epilepsy Genomewide Association International Study |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03547050 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Canada
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Greece
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Italy
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of Rolandic Epilepsy in accordance with the following international
criteria:
- Age of first afebrile seizure 3-12 years
- Seizures comprising focal sensorimotor seizures affecting the vocal tract and
face, with or without involvement of the arm
- Predominant sleep-related seizures
- EEG interictal centro-temporal spikes with normal background
2. Current age 6-25 years
Exclusion Criteria:
1. No history of focal seizure
2. Normal EEG or abnormal background features on EEG
3. Known structural causes (stroke, tuberous sclerosis, infection, post-infectious or
metabolic)
4. Primary diagnosis of autism or global learning disability
5. Focal central neurological deficit on clinical exam,
6. Unable to provide informed consent
7. Unable to provide blood sample
Age minimum:
6 Years
Age maximum:
25 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rolandic Epilepsy
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Intervention(s)
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Other: Blood draw
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Other: Existing samples
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Primary Outcome(s)
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Allelic association p value corrected for genome wide testing
[Time Frame: Day 1]
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Secondary ID(s)
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TWF 164-3020
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229844
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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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