Migraine DiseaseMAPSNCT01004835
The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
An observational study of Migraine Disease, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Migraine Disease
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.
Read the 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.
- Conditions
- Migraine Disease
- Keywords
- migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Christy M Jackson, M.D., Principal investigator, Scrippshealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004835
- Sponsor's protocol ID
- HSC# 08-5099
- Acronym
- MAPS
- Status last verified
- Oct 2015
- First submitted
- 29 Oct 2009
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
- ClinicalTrials.gov ID
- NCT01004835
- Acronym / sponsor ID
- MAPS / HSC# 08-5099
- Conditions
- Migraine Disease
- Keywords
- migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy M Jackson, M.D. principal investigator
Scrippshealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disease, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene identification (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.