The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
First received: October 29, 2009
Last updated: June 10, 2014
Last verified: June 2014
The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.
||Observational Model: Family-Based
||The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
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.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||10 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.
- 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
- 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
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
|La Jolla, California, United States, 92037 |
Scripps Translational Science Institute
||Christy M Jackson, M.D.
No publications provided
||Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 29, 2009
||June 10, 2014
||United States: Institutional Review Board
Keywords provided by Scripps Translational Science Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases