MigraineNCT03742024
Study of Pediatric Migraine: The Pediatric Migraine Registry
An observational study of Migraine, run by Duke University at 19 sites in United States.
Trial summary
This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Migraine
- How many people
- 201 participants
- Where
- 19 sitesUnited States
- Study dates
- 5 Dec 2018to 8 Feb 2021
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants aged 4-17 years old (inclusive) diagnosed with migraine with or without aura will be eligible for participation in this study.
Who may be able to join
- 4 to 17 years of age inclusive at the time of enrollment visit
- Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura
- Guardian provides informed consent/HIPAA
- Participant provides assent if developmentally appropriate and required by the institutional review board
Who cannot join
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Akron Children's Hospital
Akron, Ohio, 48109
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104
University of Maryland
Baltimore, Maryland, 21201
University of Vermont School of Medicine
Burlington, Vermont, 05401
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
The Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44195
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
University of South Carolina at Columbia
Columbia, South Carolina, 29203
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Louisville Health Sciences center
Louisville, Kentucky, 40202
Nicklaus Children's Hospital
Miami, Florida, 33155
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital, The Miriam Hospital
Providence, Rhode Island, 02903
University of California at San Francisco
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
Nemours Alfred I duPont Hospital For Children Neurology
Wilmington, Delaware, 19803
About this study
Official title: Observational Study of Pediatric Migraine: The Pediatric Migraine Registry
This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents | Children and adolescents between the ages of 4 and 17 years old (inclusive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine frequency
Number of days per month participant experiences migraine
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start5 Dec 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Christoph Hornik, MD, Principal investigator, Duke UniversityAmy Gelfand, MD, Principal investigator, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742024
- Sponsor's protocol ID
- Pro00100205
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Pediatric Migraine: The Pediatric Migraine Registry
- ClinicalTrials.gov ID
- NCT03742024
- Acronym / sponsor ID
- Pro00100205
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents | – | –Children and adolescents between the ages of 4 and 17 years old (inclusive) |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants aged 4-17 years old (inclusive) diagnosed with migraine with or without aura will be eligible for participation in this study.
Key inclusion criteria (4 listed)
- 4 to 17 years of age inclusive at the time of enrollment visit
- Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura
- Guardian provides informed consent/HIPAA
- Participant provides assent if developmentally appropriate and required by the institutional review board
Key exclusion criteria (1 listed)
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Migraine frequency
Time frame: Approximately 12 months
Number of days per month participant experiences migraine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hornik, MD principal investigator
Duke University
Amy Gelfand, MD principal investigator
University of California at San Francisco
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Duke University at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine frequency (time frame: Approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.