Vomiting Clinical Trial
Official title:
Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children
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.
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
(i.e. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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