Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-04-04 @ 12:41 PM
Study NCT ID:
NCT01884766
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2013-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Copeptin in Childhood Epilepsy
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Prospective Study on Copeptin in Childhood Epilepsy
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EpiCop
Brief Summary:
In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.
Detailed Description:
Background:
Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.
Working hypotheses:
1. Circulating copeptin concentrations are increased after generalized seizures, including FS.
2. Copeptin is predictive for complexity and relapse in FS.
Specific aims:
1. to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
2. to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.
Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.
Working hypotheses:
1. Circulating copeptin concentrations are increased after generalized seizures, including FS.
2. Copeptin is predictive for complexity and relapse in FS.
Specific aims:
1. to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
2. to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: