MigrainePhase 4NCT01071317
Trial of Comprehensive Migraine Intervention
A Phase 4 study testing Naproxen, Sumatriptan and Migraine education in people with Migraine, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Naproxen, Sumatriptan and Migraine education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine,
- Baseline migraine related disability of mild or worse,
- No current or past triptan use,
- Not satisfied with current headache care.
Who cannot join
- Allergy or contraindication to study medications,
- Daily or near daily analgesic medication use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.
- Conditions
- Migraine
- Being tested
- Naproxen, Sumatriptan, Migraine education, Reenforcement of diagnosis, Typical care
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Naproxen 500mg PO bid prn headache
SumatriptanDrug
100mg po q day prn headache
Migraine educationBehavioural
Educational program available through NIH/ national library of medicine/ X-plain
Reenforcement of diagnosisBehavioural
Patient advised has migraine headache and how the headache meets migraine criteria
Typical careOther
Care to be determined by attending physician
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive care | Experimental | Reinforcement of diagnosis, education, medications, and referral Receives: Drug: Naproxen; Drug: Sumatriptan; Behavioral: Migraine education; Behavioral: Reenforcement of diagnosis |
| Typical care | Active comparator | Usual care Receives: Other: Typical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment
Measured: 1 month after study enrollment
Secondary outcomes (3)
Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.
Measured: 1 month after study enrollment
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable
Measured: 1 month after study enrollment
Number of Participants Who Returned to the Emergency Department for Management of Headache
We report the number of patient who returned to the emergency department for management of headache
Measured: 1 month after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin W. Friedman, MD, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071317
- Sponsor's protocol ID
- 09-08-248
- Status last verified
- Aug 2018
- First submitted
- 17 Feb 2010
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine
- ClinicalTrials.gov ID
- NCT01071317
- Acronym / sponsor ID
- 09-08-248
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 26 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive care | Experimental | Drug: Naproxen, Drug: Sumatriptan, Behavioral: Migraine education, Behavioral: Reenforcement of diagnosisReinforcement of diagnosis, education, medications, and referral |
| Typical care | Active comparator | Other: Typical careUsual care |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Migraine,
- Baseline migraine related disability of mild or worse,
- No current or past triptan use,
- Not satisfied with current headache care.
Key exclusion criteria (2 listed)
- Allergy or contraindication to study medications,
- Daily or near daily analgesic medication use.
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 |
|---|---|---|
| NaproxenNaproxen 500mg PO bid prn headache | Drug | Comprehensive care |
| Sumatriptan100mg po q day prn headache | Drug | Comprehensive care |
| Migraine educationEducational program available through NIH/ national library of medicine/ X-plain | Behavioural | Comprehensive care |
| Reenforcement of diagnosisPatient advised has migraine headache and how the headache meets migraine criteria | Behavioural | Comprehensive care |
| Typical careCare to be determined by attending physician | Other | Typical care |
Primary outcome
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
Time frame: 1 month after study enrollment
This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment
3 secondary outcomes
Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
Time frame: 1 month after study enrollment
Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
Time frame: 1 month after study enrollment
Number of Participants Who Returned to the Emergency Department for Management of Headache
Time frame: 1 month after study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen, Sumatriptan and Migraine education in people with Migraine, run by Montefiore Medical Center 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 2 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 31 Aug 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale (time frame: 1 month after study enrollment). 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 31 Aug 2018.