A Phase 4 interventional study of metoclopramide and Dexamethasone in Migraine, sponsored by Montefiore Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Prevention
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 220 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Metoclopramide 10mg IV+ dexamethasone 10mg IM
Drug: metoclopramide · Drug: Dexamethasone
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
Drug: metoclopramide · Drug: methylprednisolone acetate
metoclopramide 10mg intravenous infusion over 15 minutes
dexamethasone 10mg intramuscular injection
methylprednislone acetate 160mg intramuscular injection
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.
Time frame: 7 days after discharge from emergency department
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.
Time frame: 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".
Time frame: 7 days after discharge from emergency department
| Milestone | Control | Experimental |
|---|---|---|
| Started | 109 | 111 |
| Completed | 101 | 106 |
| Not completed | 8 | 5 |
| Withdrew: Lost to follow-up | 8 | 5 |
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
| days | Control | Experimental |
|---|---|---|
| Headache Days as Self-reported by Participants | 3.0 (2.5 to 3.5) | 3.3 (2.8 to 3.9) |
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.
| Participants | Control | Experimental |
|---|---|---|
| Number of Participants With Sustained Headache Freedom | 10 | 6 |
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".
| Participants | Control | Experimental |
|---|---|---|
| Medication Preference as Assessed by Self-report | 76 | 75 |
Collected over 1 week. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/109 (0%) | 0/109 (0%) | 3/109 (2.8%) |
| Experimental | 0/111 (0%) | 0/111 (0%) | 16/111 (14.4%) |
| Event | Control | Experimental |
|---|---|---|
| Injection site reactionSkin and subcutaneous tissue disorders | 1/109 | 9/111 |
| AkathisiaNervous system disorders | 2/109 | 7/111 |
| Age, Continuous(years) | Control | Experimental | Total |
|---|---|---|---|
| Mean | 36 ± 13 | 39 ± 16 | 38 ± 15 |
| Sex: Female, Male(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Female | 93 | 94 | 187 |
| Male | 16 | 17 | 33 |
| Race and Ethnicity Not Collected(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Control | Experimental | Total |
|---|---|---|---|
| United States | 109 | 111 | 220 |
| Duration of headache(hours) | Control | Experimental | Total |
|---|---|---|---|
| Median | 48 (24 to 96) | 72 (24 to 120) | 72 (24 to 96) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Montefiore Medical Center