Headache, MigraineNCT00772473
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
An observational study of Headache, Migraine, run by Clinvest at 1 site in United States.
Trial summary
To assess CGRP levels in saliva through the evolution of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- subjects personal triptan
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at a mid west headache specialty clinic
Who may be able to join
- Ability to read, understand, and sign the informed consent
- Subject is between the ages of 18 and 65, either male or female
- Negative pregnancy test for those of childbearing potential.
- Adequate birth control as approved by the investigator if of childbearing potential
- Subjects must fulfill criteria for IHS migraine (1.1 or 1.2) with a history of 1-6 migraines per month within the past 3 months and at least 15 headache free days though out the previous three month time period
Who cannot join
- Pregnant or breast feeding
- Presence of any condition or symptoms that would knowingly alter the content of the saliva
- Presence of any medical disease or condition that would interfere with the conduct of the study
- Current use of other medications that would be contraindicated in those patients that will take triptan medications for treatment of migraine symptoms, ie. MAO inhibitors, lithium, methyergonovine, methysergide, or ergotamine-containing products
- Use of migraine preventive medications in the three months prior to screening
- History of drug or alcohol abuse that would interfere with the study
Show all 11Show fewer
- Any pathology of the salivary glands such as sialadenitis (e.g., Sjorgen's syndrome, viral or bacterial sialadenitis, obstructive sialadentitis)
- History of hypersensitivity or allergy to triptan medications
- Presence of diabetes, salivary gland tumors, liver disease, alcoholism, and neuropathy
- More than 15 days per month of headache within the past 3 months
- Participation in another investigative drug study within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
To assess CGRP levels in saliva through the evolution of migraine.
Read the detailed description
The release of CGRP is assumed to be initiated early in the migraine process and increases as the headache intensifies. Levels of CGRP will be measured during the premonitory, mild, moderate, and severe phases of a single migraine attack and compared to the baseline value determined when the subject was headache free. Understanding of the clinical evolution of migraine CGRP release may have significant implications in acute treatment.
- Conditions
- Headache, Migraine
- Being tested
- subjects personal triptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjects personal triptanOther
Subjects will treat 1 migraine attack with their usual triptan
| Study group | Role | What they receive |
|---|---|---|
| 1 group, usual acute triptan treatment | Not described Receives: Other: subjects personal triptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine.
Measured: baseline,prodrome, mild, mod., severe, 4 hrs. post dose
Secondary outcomes (1)
CGRP levels compared to no headache and as function of prodrome symptoms, prediction of mod/sev headache; compare prodrome symptoms to those reported at screening to pre-tx,tx,post tx.
Measured: screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinvest
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Roger K Cady, M.D., Principal investigator, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772473
- Sponsor's protocol ID
- Migraine IISP 33467
- Status last verified
- May 2009
- First submitted
- 13 Oct 2008
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cady RK, Vause CV, Ho TW, Bigal ME, Durham PL. Elevated saliva calcitonin gene-related peptide levels during acute migraine predict therapeutic response to rizatriptan. Headache. 2009 Oct;49(9):1258-66. doi: 10.1111/j.1526-4610.2009.01523.x.
PubMed 19788468
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
- ClinicalTrials.gov ID
- NCT00772473
- Acronym / sponsor ID
- Migraine IISP 33467
- Conditions
- Headache, Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ClinvestUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Oct 2008 (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.
To assess CGRP levels in saliva through the evolution of migraine.
Detailed description
The release of CGRP is assumed to be initiated early in the migraine process and increases as the headache intensifies. Levels of CGRP will be measured during the premonitory, mild, moderate, and severe phases of a single migraine attack and compared to the baseline value determined when the subject was headache free. Understanding of the clinical evolution of migraine CGRP release may have significant implications in acute treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group, usual acute triptan treatment | – | Other: subjects personal triptan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at a mid west headache specialty clinic
Key inclusion criteria (5 listed)
- Ability to read, understand, and sign the informed consent
- Subject is between the ages of 18 and 65, either male or female
- Negative pregnancy test for those of childbearing potential.
- Adequate birth control as approved by the investigator if of childbearing potential
- Subjects must fulfill criteria for IHS migraine (1.1 or 1.2) with a history of 1-6 migraines per month within the past 3 months and at least 15 headache free days though out the previous three month time period
Key exclusion criteria (11 listed)
- Pregnant or breast feeding
- Presence of any condition or symptoms that would knowingly alter the content of the saliva
- Presence of any medical disease or condition that would interfere with the conduct of the study
- Current use of other medications that would be contraindicated in those patients that will take triptan medications for treatment of migraine symptoms, ie. MAO inhibitors, lithium, methyergonovine, methysergide, or ergotamine-containing products
- Use of migraine preventive medications in the three months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subjects personal triptanSubjects will treat 1 migraine attack with their usual triptan | Other | 1 group, usual acute triptan treatment |
Primary outcome
Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine.
Time frame: baseline,prodrome, mild, mod., severe, 4 hrs. post dose
1 secondary outcome
CGRP levels compared to no headache and as function of prodrome symptoms, prediction of mod/sev headache; compare prodrome symptoms to those reported at screening to pre-tx,tx,post tx.
Time frame: screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment
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 25 May 2009.
- Derived from this study: PubMed 19788468Cady RK, Vause CV, Ho TW, Bigal ME, Durham PL. Elevated saliva calcitonin gene-related peptide levels during acute migraine predict therapeutic response to rizatriptan. Headache. 2009 Oct;49(9):1258-66. doi: 10.1111/j.1526-4610.2009.01523.x.
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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.
Roger K Cady, M.D. principal investigator
Clinvest
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 Headache, Migraine, run by Clinvest 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 5 inclusion and 11 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 25 May 2009. 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?
Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine. (time frame: baseline,prodrome, mild, mod., severe, 4 hrs. post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772473, which also lists 1 linked publication.
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 25 May 2009.