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CompletedNCT00727974Updated Dec 26, 2019

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

An observational study in Vomiting and Migraines, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2019-12-26.

Sponsored by Medical College of Wisconsin · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
586
Ages
Up to 21 Years
Sex
All
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Study 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).

Read the detailed 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.

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Conditions studied

  • Vomiting
  • Migraines

Keywords

  • Genome Wide Scan (GWS)
  • Mitochondrial scan
  • Family trios
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In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 586 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cyclic vomiting syndrome (CVS) may be the most severe recurrent vomiting disorder in humans. CVS is characterized by a sudden onset of rapid-fire vomiting, usually beginning in the early morning hours or upon wakening. It has a peak vomiting intensity of every 5-10 minutes (6-12 emeses) and episodes last between 2 hours and 10 days. These episodes of acute vomiting occur on average once every 2 to 4 weeks. The child returns to completely normal health between vomiting episodes. Children are diagnosed based on their specific vomiting pattern and a lack of positive findings on laboratory testing.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
586 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Diagnostic Criteria for CVS: 3 or more different episodes of vomiting, normal health between episodes, no abnormal test results to account for vomiting \[such as endoscopic biopsies (looking at a body part with a lighted tube), hydronephrosis (water block kidney drainage), cholelithiasis (gallstones), pancreatitis (swelling of the pancreas), and hypoglycemia (too little sugar in the blood)\];

  • 2

    Diagnostic Criteria for Migraine: 5 or more different headaches, complete return to health in between headaches, headaches last 2-48 hours and get in the way everyday activity, headache affects one side of head, with pounding moderate-to-severe pain, one of the following: nausea, vomiting, photophobia (fear of light), phonophobia (fear of sound).

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What researchers measure

Primary outcomes

  1. Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach.

    Time frame: 3 years

Secondary outcomes

  1. 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)

    Time frame: 3 years

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Study locations

1 site
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00727974
Lead sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
Responsible party
Katja Kovacic (Professor of Gastroenterology, M.D., Medical College of Wisconsin) — Principal investigator
First posted
Aug 5, 2008
Start date
Mar 5, 2008
Primary completion
Jun 12, 2013
Completion
Jun 12, 2013
Last update
Dec 26, 2019

Study contacts

Katja Kovacic, MD
principal investigator · Medical College of Wiconsin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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