NCT04112823

Dexamethasone for Migraine - Dose Comparison

Completed Phase 4 Results posted Last updated 20 March 2024

What this trial tests

Phase 4 trial testing Dexamethasone 4mg in Migraine in 209 participants. Completed in 31 December 2022.

Timeline

22 December 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	209
Start date	22 December 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Dexamethasone 4mg — full drug profile →
• Dexamethasone 16mg — full drug profile →

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

Montefiore Medical Center

Who can join

18 and older, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours Primary · 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."

Group	Value	95% CI
Dexamethasone 4mg	35
Dexamethasone 16mg	42

Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration Secondary · 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.

Group	Value	95% CI
Dexamethasone 4mg	77
Dexamethasone 16mg	82

Additional Headache Medication in the ED Secondary · 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.

No

Group	Value	95% CI
Dexamethasone 4mg	83
Dexamethasone 16mg	87

Yes

Group	Value	95% CI
Dexamethasone 4mg	21
Dexamethasone 16mg	18

Patient Preference for Receiving the Same Medication for a Subsequent Headache Secondary · 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.

Yes

Group	Value	95% CI
Dexamethasone 4mg	80
Dexamethasone 16mg	83

No

Group	Value	95% CI
Dexamethasone 4mg	12
Dexamethasone 16mg	7

Not sure

Group	Value	95% CI
Dexamethasone 4mg	10
Dexamethasone 16mg	12

Number of Days With Headache Secondary · One week

The median number of headache days during the week after ED discharge will be determined.

Group	Value	95% CI
Dexamethasone 4mg	2	1 – 5
Dexamethasone 16mg	2	0 – 4

Use of Additional Headache Medication After ED Discharge Secondary · Up to 24 hours

The number of participants requiring the use of additional headache medication following ED discharge will be summarized.

No

Group	Value	95% CI
Dexamethasone 4mg	55
Dexamethasone 16mg	60

Yes

Group	Value	95% CI
Dexamethasone 4mg	45
Dexamethasone 16mg	41

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexamethasone 4mg

Serious: 2/104 (2%)

Deaths: 0/104

Dexamethasone 16mg

Serious: 0/105 (0%)

Deaths: 0/105

Serious adverse events (2 terms)

Reaction	System	Dexamethasone 4mg	Dexamethasone 16mg
Cerebellar Stroke	Nervous system disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Dexamethasone 4mg	Dexamethasone 16mg
Somnolence	Nervous system disorders	—	—
Akathisia	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Stomach Pain	Gastrointestinal disorders	—	—
Palpitations	Cardiac disorders	—	—

Most-reported serious reactions: Cerebellar Stroke, Hyperglycemia.

Data from ClinicalTrials.gov NCT04112823 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine.
   Friedman BW, Solorzano C, Kessler BD, Martorello K, et al · · 2023 · cited 7× · PMID 37604662 · DOI 10.1212/wnl.0000000000207648