Brief 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.
Brief Title
Corticosteroids for Acute Migraine in the Emergency Department
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Eligibility Criteria
Inclusion Criteria:
* Migraine without aura criteria (International Classification of Headache Disorders 3B )
* Headache rated as moderate or severe in intensity
Exclusion Criteria:
* Concern for secondary cause of headache
* Contra-indications to investigational medications
* Migraine without aura criteria (International Classification of Headache Disorders 3B )
* Headache rated as moderate or severe in intensity
Exclusion Criteria:
* Concern for secondary cause of headache
* Contra-indications to investigational medications
Inclusion Criteria
Inclusion Criteria:
* Migraine without aura criteria (International Classification of Headache Disorders 3B )
* Headache rated as moderate or severe in intensity
* Migraine without aura criteria (International Classification of Headache Disorders 3B )
* Headache rated as moderate or severe in intensity
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02847494
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6342
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
Primary Outcomes
Outcome Description
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
Outcome Measure
Headache Days as Self-reported by Participants
Outcome Time Frame
7 days after discharge from emergency department
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
7 days after discharge from emergency department
Outcome Measure
Number of Participants With Sustained Headache Freedom
Outcome Description
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".
Outcome Time Frame
7 days after discharge from emergency department
Outcome Measure
Medication Preference as Assessed by Self-report
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415