NCT04112823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 22, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

September 30, 2019

Results QC Date

February 22, 2024

Last Update Submit

February 22, 2024

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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."

    48 hours

Secondary Outcomes (5)

  • Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration

    Two hours

  • Additional Headache Medication in the ED

    Up to 24 hours

  • Patient Preference for Receiving the Same Medication for a Subsequent Headache

    48 hours

  • Number of Days With Headache

    One week

  • Use of Additional Headache Medication After ED Discharge

    Up to 24 hours

Study Arms (2)

Dexamethasone 4mg

ACTIVE COMPARATOR

Dexamethasone 4mg, administered intravenously

Drug: Dexamethasone 4mg

Dexamethasone 16mg

ACTIVE COMPARATOR

Dexamethasone 16mg, administered intravenously

Drug: Dexamethasone 16mg

Interventions

Dexamethasone 4mgDRUG

Dexamethasone 4mg + metoclopramide 10mg, intravenously

Also known as: Dexasone 4 mg
Dexamethasone 4mg
Dexamethasone 16mgDRUG

Dexamethasone 16mg + metoclopramide 10mg, intravenously

Also known as: Dexasone 16 mg
Dexamethasone 16mg

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate or severe migraine

You may not qualify if:

  • Medication contra-indication
  • Concern for secondary cause of headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21.

    PMID: 37604662DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Dr. Benjamin Friedman
Organization
Montefiore Medical Center
befriedm@montefiore.org
718-920-6626

Study Officials

  • Benjamin Friedman, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

December 22, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 20, 2024

Results First Posted

March 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)