MigraineNCT02643719
Migraine Treatment in ED
A study testing Relaxation Therapy, Topiramate and Abortive Medication (Naproxen and Sumatriptan) in people with Migraine, run by NYU Langone Health.
Trial summary
Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment for migraine in the Emergency Department (ED) and prescribing migraine preventive medications in the ED. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Relaxation Therapy, Topiramate and Abortive Medication (Naproxen and Sumatriptan)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- age 18 years to 65 years of age
- primary diagnosis of migraine based on the International Classification of headache disorders 3 beta criteria
- having a migraine 3 or more days/month.
Who cannot join
- Cognitive Behavioral Therapy (CBT), biofeedback or other relaxation therapy in the past year
- being on medication used for migraine prevention (topiramate, propranolol, valproic acid, amitriptyline/nortriptyline/imipramine/desipramine, botulinum toxin, a SNRI, angiotensin-converting enzyme inhibitors (ACE-I) or ARB)
- cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
- substance or alcohol abuse as determined by self-report or prior documentation in the medical record.
About this study
Official title: Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.
Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment for migraine in the Emergency Department (ED) and prescribing migraine preventive medications in the ED. The study will examine the effect of these treatments, both individually and in combination, on pain severity and headache-related disability. This study is designed to examine the feasibility of comparing four interventions for ED patients presenting with migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group 3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4: Standard of Care.
- Conditions
- Migraine
- Being tested
- Relaxation Therapy, Topiramate, Standard of Care, Abortive Medication (Naproxen and Sumatriptan)
- Keywords
- migraine, topiramate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation TherapyBehavioural
Between 30-60 minutes after the standard of care medication administration (metoclopramide, magnesium, prochlorperazine, ketorolac, or steroids at discretion of treating physician), patient receives training in relaxation therapy.
TopiramateDrug
Preventive medication prescriptions given to the patient along with written instructions and information about side effects:
Topiramate 25mg tabs (with a plan to increase to 100mg)
Standard of CareDrug
Standard discharge instruction sheet plus standard of care medication as prescribed by treating physician. The clinical team will be instructed to address post-discharge care as appropriate
Abortive Medication (Naproxen and Sumatriptan)Drug
All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Active comparator | Not described Receives: Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan) |
| Behavioral intervention | Active comparator | Not described Receives: Behavioral: Relaxation Therapy; Drug: Abortive Medication (Naproxen and Sumatriptan) |
| topiramate and behavioral intervention | Active comparator | Not described Receives: Behavioral: Relaxation Therapy; Drug: Topiramate; Drug: Abortive Medication (Naproxen and Sumatriptan) |
| Standard of Care | Active comparator | Not described Receives: Drug: Standard of Care; Drug: Abortive Medication (Naproxen and Sumatriptan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal numeric rating scale (VNRS) scores
To examine whether there is a significant pain reduction for patients in the ED after behavioral therapy, investigators will analyze pain scores in the ED, and at 24 hours and 72 hours.
Measured: 24 hours, 72 hours
Headache Impact Test (HIT) scores
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Study team missed continuing review and study lapsed with out recruiting any subjects.
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 N/A
- 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, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643719
- Sponsor's protocol ID
- 14-01981
- Status last verified
- Aug 2018
- First submitted
- 29 Dec 2015
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.
- ClinicalTrials.gov ID
- NCT02643719
- Acronym / sponsor ID
- 14-01981
- Conditions
- Migraine
- Keywords
- migraine, topiramate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team missed continuing review and study lapsed with out recruiting any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Dec 2015 (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.
Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment for migraine in the Emergency Department (ED) and prescribing migraine preventive medications in the ED. The study will examine the effect of these treatments, both individually and in combination, on pain severity and headache-related disability. This study is designed to examine the feasibility of comparing four interventions for ED patients presenting with migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group 3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4: Standard of Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Active comparator | Drug: Topiramate, Drug: Abortive Medication (Naproxen and Sumatriptan) |
| Behavioral intervention | Active comparator | Behavioral: Relaxation Therapy, Drug: Abortive Medication (Naproxen and Sumatriptan) |
| topiramate and behavioral intervention | Active comparator | Behavioral: Relaxation Therapy, Drug: Topiramate, Drug: Abortive Medication (Naproxen and Sumatriptan) |
| Standard of Care | Active comparator | Drug: Standard of Care, Drug: Abortive Medication (Naproxen and Sumatriptan) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years to 65 years of age
- primary diagnosis of migraine based on the International Classification of headache disorders 3 beta criteria
- having a migraine 3 or more days/month.
Key exclusion criteria (4 listed)
- Cognitive Behavioral Therapy (CBT), biofeedback or other relaxation therapy in the past year
- being on medication used for migraine prevention (topiramate, propranolol, valproic acid, amitriptyline/nortriptyline/imipramine/desipramine, botulinum toxin, a SNRI, angiotensin-converting enzyme inhibitors (ACE-I) or ARB)
- cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
- substance or alcohol abuse as determined by self-report or prior documentation in the medical record.
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 |
|---|---|---|
| Relaxation TherapyBetween 30-60 minutes after the standard of care medication administration (metoclopramide, magnesium, prochlorperazine, ketorolac, or steroids at discretion of treating physician), patient receives training in relaxation therapy. | Behavioural | Behavioral intervention, topiramate and behavioral intervention |
| TopiramatePreventive medication prescriptions given to the patient along with written instructions and information about side effects: Topiramate 25mg tabs (with a plan to increase to 100mg) | Drug | Topiramate, topiramate and behavioral intervention |
| Standard of CareStandard discharge instruction sheet plus standard of care medication as prescribed by treating physician. The clinical team will be instructed to address post-discharge care as appropriate | Drug | Standard of Care |
| Abortive Medication (Naproxen and Sumatriptan)All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg) | Drug | Behavioral intervention, Standard of Care, Topiramate, topiramate and behavioral intervention |
Primary outcome
Verbal numeric rating scale (VNRS) scores
Time frame: 24 hours, 72 hours
To examine whether there is a significant pain reduction for patients in the ED after behavioral therapy, investigators will analyze pain scores in the ED, and at 24 hours and 72 hours.
Headache Impact Test (HIT) scores
Time frame: 3 Months
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 24 Aug 2018.
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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 principal investigator
New York University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Therapy, Topiramate and Abortive Medication (Naproxen and Sumatriptan) in people with Migraine, run by NYU Langone Health.
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 3 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: withdrawn, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Verbal numeric rating scale (VNRS) scores (time frame: 24 hours, 72 hours). The study lists 2 primary outcomes in all. 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 24 Aug 2018.