Clinical Trial: Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children

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 Summary:

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.


Sponsor: Monarch Medical Research

Current Primary Outcome: Reduction of cycle frequency as measured by number of days between cycles.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 1.Decreased duration of attacks (measured in hours)
  • 2.Decreased intensity of attacks (0-4 point scale; none, mild, moderate, severe, excruciating)
  • 3.Decreased associated symptoms (0-4 point scales; none, mild, moderate, severe, excruciating)
  • a. Nausea
  • b. Vomiting
  • c. Headache
  • d. Abdominal pain
  • 4.Decreased disability
  • a. PedMidas
  • b. Missed school (days per attack)
  • c. Missed work (parent(s)) (days per attack)
  • 5.Decreased use of acute therapies (e.g. anti-emetics)
  • 6.Decreased emergency department visits.


Information By: Monarch Medical Research

Dates:
Date Received: February 1, 2006
Date Started: March 2006
Date Completion:
Last Updated: January 5, 2011
Last Verified: April 2007