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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: |
NCT02415686 |
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Date of registration:
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09/04/2015 |
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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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Cardiac Arrhythmias in Dravet Syndrome
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Scientific title:
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Cardiac Arrhythmias in Dravet Syndrome: an Observational, International, Multicentre Study |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02415686 |
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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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Germany
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Netherlands
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United Kingdom
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Contacts
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Name:
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Roland Thijs, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stichting Epilepsie Instellingen Nederland (S.E.I.N.) |
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Key inclusion & exclusion criteria
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Criteria:
Cases must meet all of the following criteria:
1. DS with a known pathogenic SCN1A mutation
2. seizure frequency = 1/week (all seizure types expect for absences or myoclonias)
3. no self-harm
4. age = 6 years
Each case will be matched to two historical controls (age +/- 5 years). Controls will meet
the following criteria:
1. definite diagnosis of epilepsy
2. no clinical suspicion of DS
3. at least two seizures recorded (all seizure types expect for absences or myoclonias)
during video-EEG registration.
4. age = 6 years
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Primary Outcome(s)
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Ictal asystole (sinus arrest = 3 s) or ictal bradycardia (< 2nd heart rate percentile for age)
[Time Frame: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days]
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Secondary Outcome(s)
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Ictal QT lengthening or shortening
[Time Frame: We will record heart rate patterns during seizures with miniaturized wearable EKG-monitors for 2 periods of 10 days]
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Secondary ID(s)
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NL48765.058.15
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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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