Dexamethasone for Migraine - Dose Comparison

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Dexamethasone 4mg; Drug: Dexamethasone 16mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04112823

2019-10562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate or severe migraine

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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209 participants in 2 patient groups

Dexamethasone 4mg

Active Comparator group

Description:

Dexamethasone 4mg, administered intravenously

Treatment:

Drug: Dexamethasone 4mg

Dexamethasone 16mg

Active Comparator group

Description:

Dexamethasone 16mg, administered intravenously

Treatment:

Drug: Dexamethasone 16mg