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NCT00727974 Clinical Trial

Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines

Vomiting Clinical Trial

Official title:
Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00727974
Other study ID # 08/24
Secondary ID GC 607
Status Completed
Phase
First received
Last updated
Start date March 5, 2008
Est. completion date June 12, 2013

Study information
Verified date December 2019
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).

Description:

The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.

Recruitment information / eligibility
Status Completed
Enrollment 586
Est. completion date June 12, 2013
Est. primary completion date June 12, 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion Criteria:

- Subjects age > 22 years old Vomiting is not due to CVS or other related condition

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach. 3 years
Secondary Perform genotype-phenotype correlations between genetic profiles and various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine) 3 years
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