NCT01004835

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

6.3 years

First QC Date

October 29, 2009

Last Update Submit

October 14, 2015

Conditions

Keywords

migraine

Outcome Measures

Primary Outcomes (1)

  • Gene identification

    By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.

    end of study

Study Arms (1)

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.

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scrippshealth

La Jolla, California, 92037, United States

Location

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.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Christy M Jackson, M.D.

    Scrippshealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Scripps Translational Science Institute

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations