The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01004835
First received: October 29, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.


Condition
Migraine Disease

Study Type: Observational
Study Design: Observational Model: Family-Based
Official Title: The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Gene identification [ Time Frame: end of study ] [ Designated as safety issue: No ]
    By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.


Biospecimen Retention:   Samples With DNA

Approximately 20 milliliters of blood will be dispensed as follows: 2 X 8.5 ml PAX DNA Tubes OR 2 mLs of Saliva may be collected from each patient in a provided container. Saliva will only be collected on those individuals who do not wish to undergo phlebotomy for blood collection.


Enrollment: 61
Study Start Date: January 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.

Criteria

Inclusion Criteria:

  1. 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
  2. Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson
  3. Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented
  4. Able to understand and grant informed consent

Exclusion Criteria:

  1. Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry
  2. 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
  3. Treatment with any investigational agents or devices within 30 days preceding enrollment in the study
  4. Has undergone ECT within 90 days preceding enrollment in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004835

Locations
United States, California
Scrippshealth
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
Principal Investigator: Christy M Jackson, M.D. Scrippshealth
  More Information

Additional Information:
No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01004835     History of Changes
Other Study ID Numbers: HSC# 08-5099
Study First Received: October 29, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014