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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 4mg | Active Comparator | Dexamethasone 4mg, administered intravenously |
|
| Dexamethasone 16mg | Active Comparator | Dexamethasone 16mg, administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4mg | Drug | Dexamethasone 4mg + metoclopramide 10mg, intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Headaches Who Have Sustained Headache Relief for 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." | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration | 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. | Two hours |
| Additional Headache Medication in the ED |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37604662 | Derived | Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21. |
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Altogether, 1823 patients were screened and 209 were randomized into the study.
Enrollment commenced in December 2019, was paused between March and June 2020 when all in-person clinical research halted at our institution due to COVID, and after completion of the interim analysis, enrollment was permanently halted in August 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 4mg | Dexamethasone 4mg, administered intravenously Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously |
| FG001 | Dexamethasone 16mg | Dexamethasone 16mg, administered intravenously Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 4mg | Dexamethasone 4mg, administered intravenously Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously |
| BG001 | Dexamethasone 16mg | Dexamethasone 16mg, administered intravenously Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Headaches Who Have Sustained Headache Relief for 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." | Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm did not complete their 48 hour follow up. As such, 48 hour data was not collected from these subjects. | Posted | Count of Participants | Participants | 48 hours |
|
Up to 48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone 4mg | Dexamethasone 4mg, administered intravenously Dexamethasone 4mg: Dexamethasone 4mg + metoclopramide 10mg, intravenously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar Stroke | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Verbatim Term: Drowsiness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2022 | Feb 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone 16mg | Drug | Dexamethasone 16mg + metoclopramide 10mg, intravenously |
|
|
The number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined. |
| Up to 24 hours |
| Patient Preference for Receiving the Same Medication for a Subsequent Headache | 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. | 48 hours |
| Number of Days With Headache | The median number of headache days during the week after ED discharge will be determined. | One week |
| Use of Additional Headache Medication After ED Discharge | The number of participants requiring the use of additional headache medication following ED discharge will be summarized. | Up to 24 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Headache | Median | Inter-Quartile Range | hours |
|
| Aura Symptoms | Count of Participants | Participants |
|
| Treated Migraine Before Heading to the Emergency Department (ED) | Count of Participants | Participants |
|
| Headache Intensity | Count of Participants | Participants |
|
| OG001 |
| Dexamethasone 16mg |
Dexamethasone 16mg, administered intravenously Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously |
|
|
|
| Secondary | Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration | 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. | Posted | Count of Participants | Participants | Two hours |
|
|
|
|
| Secondary | Additional Headache Medication in the ED | The number of participants requiring the use of additional headache medication (rescue therapy) during their time in the ED will be determined. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
|
| Secondary | Patient Preference for Receiving the Same Medication for a Subsequent Headache | 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. | Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm did not complete their 48 hour follow up. As such, 48 hour data was not collected from these subjects. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Number of Days With Headache | The median number of headache days during the week after ED discharge will be determined. | Two subjects in the Dexamethasone 4mg arm and 3 subjects in the Dexamethasone 16mg arm were lost to follow up. Data was not collected from these subjects. | Posted | Median | Inter-Quartile Range | days | One week |
|
|
|
|
| Secondary | Use of Additional Headache Medication After ED Discharge | The number of participants requiring the use of additional headache medication following ED discharge will be summarized. | Data related to additional headache medication is missing for 4 participants in each treatment arm. | Posted | Count of Participants | Participants | Up to 24 hours |
|
|
|
|
| 0 |
| 104 |
| 2 |
| 104 |
| 22 |
| 104 |
| EG001 | Dexamethasone 16mg | Dexamethasone 16mg, administered intravenously Dexamethasone 16mg: Dexamethasone 16mg + metoclopramide 10mg, intravenously | 0 | 105 | 0 | 105 | 24 | 105 |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim Term: Markedly Elevated Blood Sugar |
|
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | Verbatim Terms: Weakness, Lack of Energy |
|
| Stomach Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Verbatim Term: Stomach ache |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Not sure |
|