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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
12
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, United States
Reduction of cycle frequency as measured by number of days between cycles.
Decreased duration of attacks (measured in hours)
Decreased intensity of attacks (0-4 point scale; none, mild, moderate, severe, excruciating)
Decreased associated symptoms (0-4 point scales; none, mild, moderate, severe, excruciating)
Nausea
Vomiting
Headache
Abdominal pain
Decreased disability
PedMidas
Missed school (days per attack)
Missed work (parent(s)) (days per attack)
Decreased use of acute therapies (e.g. anti-emetics)
Decreased emergency department visits.
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