Migraine
Conditions
Brief summary
Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine. All patients will also be treated with metoclopramide.
Detailed description
Investigational medications. Medications in each study arm are as follows: A. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV B. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 16 mg IV Assignment. Will be concealed. The research pharmacist will determine assignment based on a random number sequence. Randomization. Randomization will occur in blocks of 4 based on a random number generator. Blinding. Patients, clinicians, and research personnel will be blinded. Stratification. Subjects will be stratified by study site (Moses or Weiler) and baseline pain intensity (moderate or severe). Follow-up phone calls will be performed 48 hours and 7 days after ED (emergency department) discharge. At the first call, the next follow-up phone call will be scheduled. Attempts to complete the follow-up calls successfully will be made every eight hours until deemed futile. At this point, questionnaires will be sent by express courier, and failing this, the investigator will perform a home visit. At the 48-hour phone call, the focus will be assessments of pain, functional status, migraine associated features, adverse events, satisfaction with the medication received, and use of rescue medication. The focus of the seven day phone call will be on the total number of days with headache since ED discharge, the need for repeat ED visits, healthcare providers visited, days of work missed, and adverse medication effects.
Interventions
DRUGDexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate or severe migraine
Exclusion criteria
* Medication contra-indication * Concern for secondary cause of headache
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours | 48 hours | The number of subjects achieving sustained headache relief for 48 hours and maintaining this level, without requiring additional rescue therapy for the entire 48 hour follow up period, will be determined. Headache relief will be defined as the number of subjects reporting a headache intensity of either none or mild. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration | Two hours | The number of subjects who achieve a headache intensity level of either none or mild within two hours of medication administration, without requiring rescue medication, will be determined. |
| Additional Headache Medication in the ED | Up to 24 hours | The number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined. |
| Patient Preference for Receiving the Same Medication for a Subsequent Headache | 48 hours | During the 48 hour follow up patients were queried as to whether they would want the same headache treatment regimen during the onset of a subsequent headache. The number of responses were tabulated and reported. |
| Number of Days With Headache | One week | The median number of headache days during the week after ED discharge will be determined. |
| Use of Additional Headache Medication After ED Discharge | Up to 24 hours | The number of participants requiring the use of additional headache medication following ED discharge will be summarized. |
Countries
United States
Participant flow
Recruitment details
Enrollment commenced in December 2019, was paused between March and June 2020 when all in-person clinical research halted at our institution due to COVID, and after completion of the interim analysis, enrollment was permanently halted in August 2022.
Pre-assignment details
Altogether, 1823 patients were screened and 209 were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone 4mg Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously | 104 |
| Dexamethasone 16mg Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously | 105 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Dexamethasone 4mg | Dexamethasone 16mg | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 11 | 38.5 years STANDARD_DEVIATION 11 |
| Aura Symptoms No | 62 Participants | 64 Participants | 126 Participants |
| Aura Symptoms Yes | 42 Participants | 41 Participants | 83 Participants |
| Duration of Headache | 48 hours | 48 hours | 48 hours |
| Headache Intensity Moderate | 27 Participants | 31 Participants | 58 Participants |
| Headache Intensity Severe | 77 Participants | 74 Participants | 151 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 104 participants | 105 participants | 209 participants |
| Sex: Female, Male Female | 96 Participants | 83 Participants | 179 Participants |
| Sex: Female, Male Male | 8 Participants | 22 Participants | 30 Participants |
| Treated Migraine Before Heading to the Emergency Department (ED) No | 35 Participants | 42 Participants | 77 Participants |
| Treated Migraine Before Heading to the Emergency Department (ED) Yes | 69 Participants | 63 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 105 |
| other Total, other adverse events | 22 / 104 | 24 / 105 |
| serious Total, serious adverse events | 2 / 104 | 0 / 105 |
Outcome results
Primary
Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
The number of subjects achieving sustained headache relief for 48 hours and maintaining this level, without requiring additional rescue therapy for the entire 48 hour follow up period, will be determined. Headache relief will be defined as the number of subjects reporting a headache intensity of either none or mild.
Time frame: 48 hours
Population: Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm did not complete their 48 hour follow up. As such, 48 hour data was not collected from these subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 4mg | Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours | 35 Participants |
| Dexamethasone 16mg | Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours | 42 Participants |
95% CI: [-6, 20]
Secondary
Additional Headache Medication in the ED
The number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined.
Time frame: Up to 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone 4mg | Additional Headache Medication in the ED | No | 83 Participants |
| Dexamethasone 4mg | Additional Headache Medication in the ED | Yes | 21 Participants |
| Dexamethasone 16mg | Additional Headache Medication in the ED | No | 87 Participants |
| Dexamethasone 16mg | Additional Headache Medication in the ED | Yes | 18 Participants |
95% CI: [-8, 14]
Secondary
Number of Days With Headache
The median number of headache days during the week after ED discharge will be determined.
Time frame: One week
Population: Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm were lost to follow up. Data was not collected from these subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone 4mg | Number of Days With Headache | 2 days |
| Dexamethasone 16mg | Number of Days With Headache | 2 days |
95% CI: [-0.3, 1.2]
Secondary
Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration
The number of subjects who achieve a headache intensity level of either none or mild within two hours of medication administration, without requiring rescue medication, will be determined.
Time frame: Two hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 4mg | Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration | 77 Participants |
| Dexamethasone 16mg | Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration | 82 Participants |
95% CI: [-8, 16]
Secondary
Patient Preference for Receiving the Same Medication for a Subsequent Headache
During the 48 hour follow up patients were queried as to whether they would want the same headache treatment regimen during the onset of a subsequent headache. The number of responses were tabulated and reported.
Time frame: 48 hours
Population: Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm did not complete their 48 hour follow up. As such, 48 hour data was not collected from these subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone 4mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | Yes | 80 Participants |
| Dexamethasone 4mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | No | 12 Participants |
| Dexamethasone 4mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | Not sure | 10 Participants |
| Dexamethasone 16mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | Yes | 83 Participants |
| Dexamethasone 16mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | No | 7 Participants |
| Dexamethasone 16mg | Patient Preference for Receiving the Same Medication for a Subsequent Headache | Not sure | 12 Participants |
Secondary
Use of Additional Headache Medication After ED Discharge
The number of participants requiring the use of additional headache medication following ED discharge will be summarized.
Time frame: Up to 24 hours
Population: Data related to additional headache medication is missing for 4 participants in each treatment arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone 4mg | Use of Additional Headache Medication After ED Discharge | No | 55 Participants |
| Dexamethasone 4mg | Use of Additional Headache Medication After ED Discharge | Yes | 45 Participants |
| Dexamethasone 16mg | Use of Additional Headache Medication After ED Discharge | No | 60 Participants |
| Dexamethasone 16mg | Use of Additional Headache Medication After ED Discharge | Yes | 41 Participants |
95% CI: [-9, 18]