Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children|
- 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)
- Abdominal pain
- Decreased disability
- 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.
|Study Start Date:||March 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286988
|United States, Virginia|
|Monarch Medical Research - Child and Adolescent Neurology|
|Norfolk, Virginia, United States, 23510|
|Principal Investigator:||Donald W Lewis, MD||Monarch Medical Research|