MigrainePhase 4NCT02847494
Corticosteroids for Acute Migraine in the Emergency Department
A Phase 4 study testing metoclopramide, Dexamethasone and methylprednisolone acetate in people with Migraine, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- metoclopramide, Dexamethasone and methylprednisolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 30 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine without aura criteria (International Classification of Headache Disorders 3B )
- Headache rated as moderate or severe in intensity
Who cannot join
- Concern for secondary cause of headache
- Contra-indications to investigational medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Medical Center--Einstein
The Bronx, New York, 10461
Montefiore Medical Center-Moses
The Bronx, New York, 10467
About this study
Official title: Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.
- Conditions
- Migraine
- Being tested
- metoclopramide, Dexamethasone, methylprednisolone acetate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramideDrug
metoclopramide 10mg intravenous infusion over 15 minutes
DexamethasoneDrug
dexamethasone 10mg intramuscular injection
methylprednisolone acetateDrug
methylprednislone acetate 160mg intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Metoclopramide 10mg IV+ dexamethasone 10mg IM Receives: Drug: metoclopramide; Drug: Dexamethasone |
| Experimental | Active comparator | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM Receives: Drug: metoclopramide; Drug: methylprednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days as Self-reported by Participants
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
Measured: 7 days after discharge from emergency department
Secondary outcomes (2)
Number of Participants With Sustained Headache Freedom
Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.
Measured: 7 days after discharge from emergency department
Medication Preference as Assessed by Self-report
Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes".
Measured: 7 days after discharge from emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion21 Sep 2017
- Study completion30 Sep 2017
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.
- 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 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
- Investigators
- Benjamin W Friedman, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847494
- Sponsor's protocol ID
- 2016-6342
- Status last verified
- Dec 2018
- First submitted
- 25 Jul 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.
PubMed 30449536
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02847494
- Acronym / sponsor ID
- 2016-6342
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: metoclopramide, Drug: DexamethasoneMetoclopramide 10mg IV+ dexamethasone 10mg IM |
| Experimental | Active comparator | Drug: metoclopramide, Drug: methylprednisolone acetateMetoclopramide 10mg IV + methylprednisolone acetate 160mg IM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Migraine without aura criteria (International Classification of Headache Disorders 3B )
- Headache rated as moderate or severe in intensity
Key exclusion criteria (2 listed)
- Concern for secondary cause of headache
- Contra-indications to investigational medications
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 |
|---|---|---|
| metoclopramidemetoclopramide 10mg intravenous infusion over 15 minutes | Drug | Control, Experimental |
| Dexamethasonedexamethasone 10mg intramuscular injection | Drug | Control |
| methylprednisolone acetatemethylprednislone acetate 160mg intramuscular injection | Drug | Experimental |
Primary outcome
Headache Days as Self-reported by Participants
Time frame: 7 days after discharge from emergency department
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
2 secondary outcomes
Number of Participants With Sustained Headache Freedom
Time frame: 7 days after discharge from emergency department
Medication Preference as Assessed by Self-report
Time frame: 7 days after discharge from emergency department
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30449536Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.
- Individual participant dataSharing planned: No
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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.
Benjamin W Friedman, MD, MS principal investigator
Albert Einstein College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metoclopramide, Dexamethasone and methylprednisolone acetate in people with Migraine, run by Montefiore Medical Center at 2 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?
The sponsor lists 2 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 8 Jan 2019). 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?
Headache Days as Self-reported by Participants (time frame: 7 days after discharge from emergency department). 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 NCT02847494, 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 8 Jan 2019.