- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01004835
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS) (MAPS)
October 14, 2015 updated by: Eric Topol, MD, Scripps Translational Science Institute
The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.
Study Overview
Status
Completed
Conditions
Detailed Description
It is estimated that over one-third of the world's population suffers from persistent or recurrent pain.
Migraine is highly heritable and the majority of juveniles who suffer from the disorder have a mother or father who also have the disease.
The blood or saliva samples will go through DNA analysis and be sequenced for candidate genes or subjected to whole-genome sequencing.
By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Scrippshealth
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.
Description
Inclusion Criteria:
- Family members (genetic duo or trio), consisting of an adolescent 10 to 18 years of age and at least one of their biologic parents willing to be participate in trial
- Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson
- Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented
- Able to understand and grant informed consent
Exclusion Criteria:
- Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry
- Has a significant chronic medical condition (i.e.chronic meningitis or a secondary origin/cause of headache) which, in the investigator's option, may interfere with the patient's optimal participation in the study
- Treatment with any investigational agents or devices within 30 days preceding enrollment in the study
- Has undergone ECT within 90 days preceding enrollment in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Migraine Disease
Patients 10 to 18 years of age with the diagnosis of Migraine disease and at least one of their biologic parents will be included in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene identification
Time Frame: end of study
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By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.
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end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christy M Jackson, M.D., Scrippshealth
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
October 29, 2009
First Submitted That Met QC Criteria
October 29, 2009
First Posted (Estimate)
October 30, 2009
Study Record Updates
Last Update Posted (Estimate)
October 16, 2015
Last Update Submitted That Met QC Criteria
October 14, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC# 08-5099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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