A Phase 3 interventional study of metoclopramide and metoclopramide in Migraine, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by Montefiore Medical Center · Phase 3, Interventional, and Treatment
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 349 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 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
Drug: metoclopramide · Drug: Diphenhydramine 25mg
metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
Drug: metoclopramide · Drug: Diphenhydramine 25mg
metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
Drug: metoclopramide · Drug: Diphenhydramine 25mg
metoclopramide 20 mg
metoclopramide 40 mg
metoclopramide 10 mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Pain Intensity Score
Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
Time frame: Baseline, 60 minutes
| Milestone | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg Intravenous | Metoclopramide 40 mg Intravenous |
|---|---|---|---|
| Started | 113 | 118 | 118 |
| Completed | 113 | 117 | 117 |
| Not completed | 0 | 1 | 1 |
| Milestone | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg Intravenous | Metoclopramide 40 mg Intravenous |
|---|---|---|---|
| Started | 113 | 117 | 117 |
| Completed | 107 | 111 | 106 |
| Not completed | 6 | 6 | 11 |
Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
| scores on a scale | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg |
|---|---|---|---|
| Pain Intensity Score | 4.7 ± 2.6 | 4.9 ± 2.8 | 5.3 ± 2.8 |
Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metoclopramide 10 mg Intravenous | — | 0/113 (0%) | 8/113 (7.1%) |
| Metoclopramide 20 mg | — | 1/118 (0.8%) | 8/118 (6.8%) |
| Metoclopramide 40 mg | — | 0/118 (0%) | 7/118 (5.9%) |
| Event | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg |
|---|---|---|---|
| EncephalitisNervous system disorders | 0/113 | 1/118 | 0/118 |
| Event | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg |
|---|---|---|---|
| AkathisiaNervous system disorders | 8/113 | 8/118 | 7/118 |
| Age, Continuous(years) | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg | Total |
|---|---|---|---|---|
| Adults | 38.7 ± 11.5 | 37.5 ± 9.9 | 38.4 ± 12.0 | 38.2 ± 11.1 |
| Sex: Female, Male(Participants) | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg | Total |
|---|---|---|---|---|
| Female | 94 | 103 | 97 | 294 |
| Male | 19 | 15 | 21 | 55 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Montefiore Medical Center