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NCT02847494

Corticosteroids for Acute Migraine in the Emergency Department

Completed Phase 4 Results posted Last updated 8 January 2019
What this trial tests

Phase 4 trial testing metoclopramide in Migraine in 220 participants. Completed in 30 September 2017.

Timeline
1 September 2016
Primary endpoint
21 September 2017
30 September 2017

Quick facts

Lead sponsorMontefiore Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment220
Start date1 September 2016
Primary completion21 September 2017
Estimated completion30 September 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Montefiore Medical Center

Who can join

18 and older, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Headache Days as Self-reported by Participants Primary · 7 days after discharge from emergency department

At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.

GroupValue95% CI
Control3.02.5 – 3.5
Experimental3.32.8 – 3.9
Number of Participants With Sustained Headache Freedom Secondary · 7 days after discharge from emergency department

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.

GroupValue95% CI
Control10
Experimental6
Medication Preference as Assessed by Self-report Secondary · 7 days after discharge from emergency department

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".

GroupValue95% CI
Control76
Experimental75

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 week. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control
Serious: 0/109 (0%)
Deaths: 0/109
Experimental
Serious: 0/111 (0%)
Deaths: 0/111
Other adverse events (2 terms — click to expand)

ReactionSystemControlExperimental
Injection site reactionSkin and subcutaneous tissue disorders
AkathisiaNervous system disorders

Data from ClinicalTrials.gov NCT02847494 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of metoclopramide

Trials testing the same drug.

Other recruiting trials for Migraine

Currently open trials in the same condition.

Other Montefiore Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02847494.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing