Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286988
Status:
TERMINATED
Last Update Posted:
2011-01-06
First Post:
2006-02-01
Brief Title:
Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children
Sponsor:
Monarch Medical Research
Organization:
Monarch Medical Research
Study Overview
Official Title:
Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient potential subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effectiveness tolerability and safety of oral topiramate for the preventative management of Cyclic Vomiting Syndrome It is believed that topiramate will decrease the frequency duration and severity of attacks experienced by children and adolescents with Cyclic Vomiting Syndrome
Detailed Description:
There is very little controlled data on the preventative treatment for Cyclic Vomiting Syndrome The existing evidence consists of small retrospective clinical series that evaluate symptomatic responses to five medications including cyproheptadine propranolol amitriptyline phenobarbital and pizotifen n 10 These published data consist of uncontrolled or retrospective reports In addition varying inclusion criteria and outcomes ie obtained by family recall were used in these studies limiting the basis upon which to compare relative effectiveness
During the prospective baseline period the subject will maintain cyclical vomiting records in which all headache occurrences will be recorded and characterized Cyclical vomiting records will be maintained throughout the study The purpose of this study is to assess the effectiveness tolerability and safety of oral topiramate for the preventative management of Cyclic Vomiting Syndrome using a prospective design established diagnostic criteria ICHD 2004 and defined objective primary and secondary endpoints
During the prospective baseline period the subject will maintain cyclical vomiting records in which all headache occurrences will be recorded and characterized Cyclical vomiting records will be maintained throughout the study The purpose of this study is to assess the effectiveness tolerability and safety of oral topiramate for the preventative management of Cyclic Vomiting Syndrome using a prospective design established diagnostic criteria ICHD 2004 and defined objective primary and secondary endpoints
Study Oversight
Has Oversight DMC:
None
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?:
None