Migraine
Conditions
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.
Interventions
methylprednislone acetate 160mg intramuscular injection
DRUGmetoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
DRUGDexamethasone
dexamethasone 10mg intramuscular injection
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Days as Self-reported by Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Headache Freedom | 7 days after discharge from emergency department | 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. |
| Medication Preference as Assessed by Self-report | 7 days after discharge from emergency department | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Metoclopramide 10mg IV+ dexamethasone 10mg IM
metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes
Dexamethasone: dexamethasone 10mg intramuscular injection | 109 |
| Experimental Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes
methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection | 111 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | Experimental | Total | Control |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 16 | 38 years STANDARD_DEVIATION 15 | 36 years STANDARD_DEVIATION 13 |
| Duration of headache | 72 hours | 72 hours | 48 hours |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 111 Participants | 220 Participants | 109 Participants |
| Sex: Female, Male Female | 94 Participants | 187 Participants | 93 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 111 |
| other Total, other adverse events | 3 / 109 | 16 / 111 |
| serious Total, serious adverse events | 0 / 109 | 0 / 111 |
Outcome results
Primary
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.
Time frame: 7 days after discharge from emergency department
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Headache Days as Self-reported by Participants | 3.0 days |
| Experimental | Headache Days as Self-reported by Participants | 3.3 days |
Secondary
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.
Time frame: 7 days after discharge from emergency department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Medication Preference as Assessed by Self-report | 76 Participants |
| Experimental | Medication Preference as Assessed by Self-report | 75 Participants |
Secondary
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.
Time frame: 7 days after discharge from emergency department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Sustained Headache Freedom | 10 Participants |
| Experimental | Number of Participants With Sustained Headache Freedom | 6 Participants |