Clinical trial NCT04112823: Dexamethasone for Migraine - Dose Comparison
Official title: Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Moderate or severe migraine

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration
timeFrame: Two hours
measure: Additional Headache Medication in the ED
timeFrame: Up to 24 hours
measure: Patient Preference for Receiving the Same Medication for a Subsequent Headache
timeFrame: 48 hours
measure: Number of Days With Headache
timeFrame: One week
measure: Use of Additional Headache Medication After ED Discharge
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: