Trial Outcomes & Findings for Dexamethasone for Migraine - Dose Comparison (NCT NCT04112823)
NCT ID: NCT04112823
Last Updated: 2024-03-20
Results Overview
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."
COMPLETED
PHASE4
209 participants
48 hours
2024-03-20
Participant Flow
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.
Altogether, 1823 patients were screened and 209 were randomized into the study.
Participant milestones
| Measure |
Dexamethasone 4mg
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
105
|
|
Overall Study
COMPLETED
|
102
|
102
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Dexamethasone 4mg
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexamethasone 4mg
n=104 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=105 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11 • n=104 Participants
|
37 years
STANDARD_DEVIATION 11 • n=105 Participants
|
38.5 years
STANDARD_DEVIATION 11 • n=209 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=104 Participants
|
83 Participants
n=105 Participants
|
179 Participants
n=209 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=104 Participants
|
22 Participants
n=105 Participants
|
30 Participants
n=209 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
104 participants
n=104 Participants
|
105 participants
n=105 Participants
|
209 participants
n=209 Participants
|
|
Duration of Headache
|
48 hours
n=104 Participants
|
48 hours
n=105 Participants
|
48 hours
n=209 Participants
|
|
Aura Symptoms
No
|
62 Participants
n=104 Participants
|
64 Participants
n=105 Participants
|
126 Participants
n=209 Participants
|
|
Aura Symptoms
Yes
|
42 Participants
n=104 Participants
|
41 Participants
n=105 Participants
|
83 Participants
n=209 Participants
|
|
Treated Migraine Before Heading to the Emergency Department (ED)
No
|
35 Participants
n=104 Participants
|
42 Participants
n=105 Participants
|
77 Participants
n=209 Participants
|
|
Treated Migraine Before Heading to the Emergency Department (ED)
Yes
|
69 Participants
n=104 Participants
|
63 Participants
n=105 Participants
|
132 Participants
n=209 Participants
|
|
Headache Intensity
Moderate
|
27 Participants
n=104 Participants
|
31 Participants
n=105 Participants
|
58 Participants
n=209 Participants
|
|
Headache Intensity
Severe
|
77 Participants
n=104 Participants
|
74 Participants
n=105 Participants
|
151 Participants
n=209 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: 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.
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."
Outcome measures
| Measure |
Dexamethasone 4mg
n=102 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=102 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
|
35 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Two hoursThe 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.
Outcome measures
| Measure |
Dexamethasone 4mg
n=104 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=105 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration
|
77 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hoursThe number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined.
Outcome measures
| Measure |
Dexamethasone 4mg
n=104 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=105 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Additional Headache Medication in the ED
No
|
83 Participants
|
87 Participants
|
|
Additional Headache Medication in the ED
Yes
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Dexamethasone 4mg
n=102 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=102 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Patient Preference for Receiving the Same Medication for a Subsequent Headache
No
|
12 Participants
|
7 Participants
|
|
Patient Preference for Receiving the Same Medication for a Subsequent Headache
Yes
|
80 Participants
|
83 Participants
|
|
Patient Preference for Receiving the Same Medication for a Subsequent Headache
Not sure
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: One weekPopulation: 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.
The median number of headache days during the week after ED discharge will be determined.
Outcome measures
| Measure |
Dexamethasone 4mg
n=102 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=102 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Number of Days With Headache
|
2 days
Interval 1.0 to 5.0
|
2 days
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Data related to additional headache medication is missing for 4 participants in each treatment arm.
The number of participants requiring the use of additional headache medication following ED discharge will be summarized.
Outcome measures
| Measure |
Dexamethasone 4mg
n=100 Participants
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=101 Participants
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Use of Additional Headache Medication After ED Discharge
No
|
55 Participants
|
60 Participants
|
|
Use of Additional Headache Medication After ED Discharge
Yes
|
45 Participants
|
41 Participants
|
Adverse Events
Dexamethasone 4mg
Dexamethasone 16mg
Serious adverse events
| Measure |
Dexamethasone 4mg
n=104 participants at risk
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=105 participants at risk
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Nervous system disorders
Cerebellar Stroke
|
0.96%
1/104 • Number of events 1 • Up to 48 hours
|
0.00%
0/105 • Up to 48 hours
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.96%
1/104 • Number of events 1 • Up to 48 hours
|
0.00%
0/105 • Up to 48 hours
|
Other adverse events
| Measure |
Dexamethasone 4mg
n=104 participants at risk
Dexamethasone 4mg, administered intravenously
Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously
|
Dexamethasone 16mg
n=105 participants at risk
Dexamethasone 16mg, administered intravenously
Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
3.8%
4/104 • Up to 48 hours
|
8.6%
9/105 • Up to 48 hours
|
|
Nervous system disorders
Dizziness
|
4.8%
5/104 • Up to 48 hours
|
3.8%
4/105 • Up to 48 hours
|
|
Nervous system disorders
Akathisia
|
7.7%
8/104 • Up to 48 hours
|
6.7%
7/105 • Up to 48 hours
|
|
General disorders
Fatigue
|
2.9%
3/104 • Up to 48 hours
|
1.9%
2/105 • Up to 48 hours
|
|
Gastrointestinal disorders
Stomach Pain
|
1.9%
2/104 • Up to 48 hours
|
0.95%
1/105 • Up to 48 hours
|
|
Cardiac disorders
Palpitations
|
1.9%
2/104 • Up to 48 hours
|
0.95%
1/105 • Up to 48 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place