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Sponsors and Collaborators: |
Monarch Medical Research Ortho-McNeil Neurologics, Inc. |
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Information provided by: | Monarch Medical Research |
ClinicalTrials.gov Identifier: | NCT00286988 |
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.
Condition | Intervention | Phase |
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Vomiting |
Drug: Topiramate |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children |
Estimated Enrollment: | 12 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2007 |
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.
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet the2004 ICHD Criteria for Cyclical Vomiting.
If female, subjects must:
Exclusion Criteria
Contact: Sharon K Cole, BSN | 757-669-9932 | sharon.cole@chkd.org |
Contact: Kristy E Scott | 757-668-9167 | scottke@chkd.org |
United States, Virginia | |
Monarch Medical Research - Child and Adolescent Neurology | Recruiting |
Norfolk, Virginia, United States, 23510 | |
Sub-Investigator: Ludwig M Frank, MD | |
Sub-Investigator: Ralph S Northam, MD | |
Sub-Investigator: Svinder S Toor, MD | |
Sub-Investigator: Luis A Batres, MD | |
Sub-Investigator: Gregory E Kobak, MD | |
Sub-Investigator: Victor M Tsou, MD | |
Sub-Investigator: Lauren K Willis, MD |
Principal Investigator: | Donald W Lewis, MD | Monarch Medical Research |
Study ID Numbers: | TOPMAT-EME-4001 |
Study First Received: | February 1, 2006 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00286988 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Preventative Open-Label Safety/Efficacy |
Anti-Obesity Agents Signs and Symptoms Vomiting Signs and Symptoms, Digestive |
Topiramate Cyclic Vomiting Syndrome Neuroprotective Agents Anticonvulsants |
Anti-Obesity Agents Signs and Symptoms Vomiting Signs and Symptoms, Digestive Therapeutic Uses Physiological Effects of Drugs |
Topiramate Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |