Dexamethasone for Migraine - Dose Comparison

Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Dexamethasone 4mg; Drug: Dexamethasone 16mg

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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate or severe migraine

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone 4mg; Dexamethasone 4mg, administered intravenously	Drug: Dexamethasone 4mg; Dexamethasone 4mg + metoclopramide 10mg, intravenously; Other Names: Dexasone 4 mg
Active Comparator: Dexamethasone 16mg; Dexamethasone 16mg, administered intravenously	Drug: Dexamethasone 16mg; Dexamethasone 16mg + metoclopramide 10mg, intravenously; Other Names: Dexasone 16 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two hours
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.	Up to 24 hours
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.	48 hours
Number of Days With Headache	The median number of headache days during the week after ED discharge will be determined.	One week
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.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 2019-10562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes