Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Metoclopramide 10mg IV+ dexamethasone 10mg IM |
|
| Experimental | Active Comparator | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoclopramide | Drug | metoclopramide 10mg intravenous infusion over 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days as Self-reported by Participants | At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. | 7 days after discharge from emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Headache Freedom | Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin W Friedman, MD, MS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center--Einstein | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center-Moses |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30449536 | Derived | Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection |
| FG001 | Experimental | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection |
| BG001 | Experimental |
| 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 | Headache Days as Self-reported by Participants | At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. | Posted | Mean | 95% Confidence Interval | days | 7 days after discharge from emergency department |
|
1 week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin W. Friedman, MD | Montefiore Health | 17189206626 | befriedm@montefiore.org |
Not provided
| 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 22, 2016 | Dec 18, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D003907 | Dexamethasone |
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexamethasone | Drug | dexamethasone 10mg intramuscular injection |
|
| methylprednisolone acetate | Drug | methylprednislone acetate 160mg intramuscular injection |
|
| 7 days after discharge from emergency department |
| Medication Preference as Assessed by Self-report | Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes". | 7 days after discharge from emergency department |
| The Bronx |
| New York |
| 10467 |
| United States |
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes
methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
| 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 | Count of Participants | Participants |
|
| Duration of headache | Median | Inter-Quartile Range | hours |
|
|
|
| Secondary | Number of Participants With Sustained Headache Freedom | Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. | Posted | Count of Participants | Participants | 7 days after discharge from emergency department |
|
|
|
| Secondary | Medication Preference as Assessed by Self-report | Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded "yes". | Posted | Count of Participants | Participants | 7 days after discharge from emergency department |
|
|
|
| 0 |
| 109 |
| 0 |
| 109 |
| 3 |
| 109 |
| EG001 | Experimental | Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection | 0 | 111 | 0 | 111 | 16 | 111 |
| Injection site reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |