Dexamethasone for Migraine - Dose Comparison
Primary Purpose
Migraine
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 4mg
Dexamethasone 16mg
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Moderate or severe migraine
Exclusion Criteria:
- Medication contra-indication
- Concern for secondary cause of headache
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone 4mg
Dexamethasone 16mg
Arm Description
Dexamethasone 4mg, administered intravenously
Dexamethasone 16mg, administered intravenously
Outcomes
Primary Outcome Measures
Number of subjects with headaches who have sustained headache relief for 48 hours
The primary outcome for this study will be sustained headache relief for 48 hours: achieving a headache intensity = "none" or "mild" within two hours of medication administration and maintaining this level, without requiring additional headache medication, for the entire 48 follow-up period
Secondary Outcome Measures
Number of subjects with headache who have relief within two hours of medication administration
achieving a headache level = mild or none within two hours of medication administration without requiring rescue medication
Number of days with headache
Number of headache days during the week after ED discharge
Full Information
NCT ID
NCT04112823
First Posted
September 30, 2019
Last Updated
September 6, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04112823
Brief Title
Dexamethasone for Migraine - Dose Comparison
Official Title
Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone 4mg
Arm Type
Active Comparator
Arm Description
Dexamethasone 4mg, administered intravenously
Arm Title
Dexamethasone 16mg
Arm Type
Active Comparator
Arm Description
Dexamethasone 16mg, administered intravenously
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4mg
Other Intervention Name(s)
Dexasone 4 mg
Intervention Description
Dexamethasone 4mg + metoclopramide 10mg, intravenously
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 16mg
Other Intervention Name(s)
Dexasone 16 mg
Intervention Description
Dexamethasone 16mg + metoclopramide 10mg, intravenously
Primary Outcome Measure Information:
Title
Number of subjects with headaches who have sustained headache relief for 48 hours
Description
The primary outcome for this study will be sustained headache relief for 48 hours: achieving a headache intensity = "none" or "mild" within two hours of medication administration and maintaining this level, without requiring additional headache medication, for the entire 48 follow-up period
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of subjects with headache who have relief within two hours of medication administration
Description
achieving a headache level = mild or none within two hours of medication administration without requiring rescue medication
Time Frame
Two hours
Title
Number of days with headache
Description
Number of headache days during the week after ED discharge
Time Frame
One week
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate or severe migraine
Exclusion Criteria:
Medication contra-indication
Concern for secondary cause of headache
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexamethasone for Migraine - Dose Comparison
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