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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004835
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Tracking Information
First Submitted Date October 29, 2009
First Posted Date October 30, 2009
Last Update Posted Date October 16, 2015
Study Start Date January 2009
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2013)
Gene identification [ Time Frame: end of study ]
By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01004835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Official Title The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Brief Summary The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.
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
Study Design Observational Model: Family-Based
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.
Condition Migraine Disease
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2009)
61
Original Actual Enrollment Same as current
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01004835
Other Study ID Numbers HSC# 08-5099
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eric Topol, MD, Scripps Translational Science Institute
Study Sponsor Scripps Translational Science Institute
Collaborators Not Provided
Investigators
Principal Investigator: Christy M Jackson, M.D. Scrippshealth
PRS Account Scripps Translational Science Institute
Verification Date October 2015