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Completed

NCT Number: NCT04112823

Dexamethasone for Migraine - Dose Comparison

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate or severe migraine

Exclusion criteria

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

Treatment and study plan

Dexamethasone 4mg

Drug

Dexamethasone 4mg + metoclopramide 10mg, intravenously

Other names: Dexasone 4 mg

Dexamethasone 16mg

Drug

Dexamethasone 16mg + metoclopramide 10mg, intravenously

Other names: Dexasone 16 mg

Primary outcomes

  1. Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours

    Time frame: 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."

Secondary outcomes

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

    Time frame: 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.

  2. Additional Headache Medication in the ED

    Time frame: 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.

  3. Patient Preference for Receiving the Same Medication for a Subsequent Headache

    Time frame: 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.

  4. Number of Days With Headache

    Time frame: One week

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

  5. Use of Additional Headache Medication After ED Discharge

    Time frame: Up to 24 hours

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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2019
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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