NCT04112823

Dexamethasone for Migraine - Dose Comparison

Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Dexamethasone 4mg	Dexamethasone 4mg + metoclopramide 10mg, intravenously
DRUG	Dexamethasone 16mg	Dexamethasone 16mg + metoclopramide 10mg, intravenously

Timeline

• Start date: 2019-12-22
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-10-02
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study