MigrainePhase 4NCT02945839
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
A Phase 4 study testing Preventative Medication (PM) and PMR (progressive muscle relaxation therapy) in people with Migraine, run by NYU Langone Health at 1 site in United States.
Trial summary
Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine
- What is being tested?
- Preventative Medication (PM) and PMR (progressive muscle relaxation therapy)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2016to Dec 2019
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month
- Migraine Disability Assessment (MIDAS) score >5.
Who cannot join
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- Opioid or barbiturate use 10+ days a month;
- PHQ9 score of severe depression;
- Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;
- Not having a smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.
Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.
Read the detailed description
Investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment, migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the intervention group will be compared with data from an enhanced usual care (EUC) group to examine the efficacy of the combined treatment effects.
- Conditions
- Migraine
- Being tested
- Preventative Medication (PM), Enhanced Usual Care, PMR (progressive muscle relaxation therapy)
- Keywords
- Migraine, emergency department
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventative Medication (PM)Drug
Also called Topiramate
Subjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence.
Enhanced Usual CareBehavioural
General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
PMR (progressive muscle relaxation therapy)Behavioural
Technique for learning to monitor and control the state of muscular tension
| Study group | Role | What they receive |
|---|---|---|
| Acute Treatment+ED-initiated preventive medication +PMR | Active comparator | All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy Receives: Drug: Preventative Medication (PM); Behavioral: Enhanced Usual Care; Behavioral: PMR (progressive muscle relaxation therapy) |
| Enhanced Usual Care (EUC) | Active comparator | Subjects will be given a general education session consisting of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. Any migraine treatment decisions on discharge will be left up to the ED attending. The RC will load the APP onto the subjects' smart phones but the PMR component will be blocked on the version of the APP that they receive. All subjects will be asked to track headache frequency, intensity, and acute medication use on the APP. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
A decrease of 3 points in the MIDAS score corresponds to a one day reduction in headache related disability per month, a clinically meaningful difference.
Measured: 12 Weeks
Secondary outcomes (3)
Perceived Stress Scale (PSS)
PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.
Measured: 12 Weeks
Number of days/week treated with acute medications
Measured: 12 Weeks
Number of drug administrations/week for acute medications
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start28 Dec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Significant changes have been made to the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mia Minen, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945839
- Sponsor's protocol ID
- 16-00548
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2016
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
- ClinicalTrials.gov ID
- NCT02945839
- Acronym / sponsor ID
- 16-00548
- Conditions
- Migraine
- Keywords
- Migraine, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Significant changes have been made to the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Oct 2016 (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.
Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.
Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.
Detailed description
Investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment, migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the intervention group will be compared with data from an enhanced usual care (EUC) group to examine the efficacy of the combined treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Treatment+ED-initiated preventive medication +PMR | Active comparator | Drug: Preventative Medication (PM), Behavioral: Enhanced Usual Care, Behavioral: PMR (progressive muscle relaxation therapy)All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareSubjects will be given a general education session consisting of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. Any migraine treatment decisions on discharge will be left up to the ED attending. The RC will load the APP onto the subjects' smart phones but the PMR component will be blocked on the version of the APP that they receive. All subjects will be asked to track headache frequency, intensity, and acute medication use on the APP. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month
- Migraine Disability Assessment (MIDAS) score >5.
Key exclusion criteria (6 listed)
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- Opioid or barbiturate use 10+ days a month;
- PHQ9 score of severe depression;
- Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;
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 |
|---|---|---|
| Preventative Medication (PM)Also: TopiramateSubjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence. | Drug | Acute Treatment+ED-initiated preventive medication +PMR |
| Enhanced Usual CareGeneral Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. | Behavioural | Acute Treatment+ED-initiated preventive medication +PMR, Enhanced Usual Care (EUC) |
| PMR (progressive muscle relaxation therapy)Technique for learning to monitor and control the state of muscular tension | Behavioural | Acute Treatment+ED-initiated preventive medication +PMR |
Primary outcome
Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
Time frame: 12 Weeks
A decrease of 3 points in the MIDAS score corresponds to a one day reduction in headache related disability per month, a clinically meaningful difference.
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: 12 Weeks
Number of days/week treated with acute medications
Time frame: 12 Weeks
Number of drug administrations/week for acute medications
Time frame: 12 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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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.
Mia Minen, MD principal investigator
New York University Medical School
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 Preventative Medication (PM) and PMR (progressive muscle relaxation therapy) in people with Migraine, run by NYU Langone Health 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Nov 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Disability Assessment Scale (MIDAS) at 3 Months and Baseline (time frame: 12 Weeks). 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 29 Nov 2019.