MigraineNCT00890357
Identifying Factors Underlying the Discontinuation of Triptans
An observational study of Migraine and Medication Adherence, run by Mayo Clinic at 3 sites in United States.
Trial summary
The objective of this study is to identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Medication Adherence
- How many people
- 292 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Specialty Headache Clinics
Triptan User Inclusion Criteria:
- Episodic Migraine or Chronic Migraine
- Have used a triptan medication in the prior 3 months
- Have used triptan medications for at least 1 year
Triptan Discontinuation Inclusion Criteria:
- Episodic Migraine or Chronic Migraine
- Used any triptan medication in the last 2 years
- Have not used a triptan medication in the last 6 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida College of Medicine
Tampa, Florida, 33612
About this study
The objective of this study is to identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation.
- Conditions
- Migraine, Medication Adherence
- Medical subject headings
- Migraine Disorders, Medication Adherence
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 |
|---|---|---|
| Triptan User | Not described | |
| Triptan Discontinued | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJun 2012
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 MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Todd J. Schwedt, Mayo Clinic
- Investigators
- Todd Schwedt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890357
- Sponsor's protocol ID
- 09-0111
- Status last verified
- Mar 2013
- First submitted
- 27 Apr 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wells RE, Markowitz SY, Baron EP, Hentz JG, Kalidas K, Mathew PG, Halker R, Dodick DW, Schwedt TJ. Identifying the factors underlying discontinuation of triptans. Headache. 2014 Feb;54(2):278-89. doi: 10.1111/head.12198. Epub 2013 Sep 3.
PubMed 24001117
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Factors Underlying the Discontinuation of Triptans
- ClinicalTrials.gov ID
- NCT00890357
- Acronym / sponsor ID
- 09-0111
- Conditions
- Migraine, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Apr 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 identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptan User | – | – |
| Triptan Discontinued | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Specialty Headache Clinics
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
Not reported in the source record.
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 29 Mar 2013.
- Derived from this study: PubMed 24001117Wells RE, Markowitz SY, Baron EP, Hentz JG, Kalidas K, Mathew PG, Halker R, Dodick DW, Schwedt TJ. Identifying the factors underlying discontinuation of triptans. Headache. 2014 Feb;54(2):278-89. doi: 10.1111/head.12198. Epub 2013 Sep 3.
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
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.
Todd Schwedt, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Medication Adherence, run by Mayo Clinic at 3 sites 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?
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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00890357, 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 29 Mar 2013.