Dexamethasone for Migraine - Dose Comparison

Migraine Clinical Trial

Official title:

Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112823
• Other study ID #: 2019-10562
• Status: Completed
• Phase: Phase 4
• Start date: December 22, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate or severe migraine

Exclusion Criteria:

• Medication contra-indication

• Concern for secondary cause of headache

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Dexamethasone 4mg
Dexamethasone 4mg + metoclopramide 10mg, intravenously
• Dexamethasone 16mg
Dexamethasone 16mg + metoclopramide 10mg, intravenously

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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."	48 hours
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.	Two hours
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.	Up to 24 hours
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.	48 hours
Secondary	Number of Days With Headache	The median number of headache days during the week after ED discharge will be determined.	One week
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.	Up to 24 hours