Trial Outcomes & Findings for Corticosteroids for Acute Migraine in the Emergency Department (NCT NCT02847494)

NCT ID: NCT02847494

Last Updated: 2019-01-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 220 participants
• Primary outcome timeframe: 7 days after discharge from emergency department
• Results posted on: 2019-01-08

Participant Flow

Participant milestones

Measure	Control Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Overall Study STARTED	109	111
Overall Study COMPLETED	101	106
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Measure	Control Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Overall Study Lost to Follow-up	8	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=109 Participants Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental n=111 Participants Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection	Total n=220 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 13 • n=109 Participants	39 years STANDARD_DEVIATION 16 • n=111 Participants	38 years STANDARD_DEVIATION 15 • n=220 Participants
Sex: Female, Male Female	93 Participants n=109 Participants	94 Participants n=111 Participants	187 Participants n=220 Participants
Sex: Female, Male Male	16 Participants n=109 Participants	17 Participants n=111 Participants	33 Participants n=220 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	109 Participants n=109 Participants	111 Participants n=111 Participants	220 Participants n=220 Participants
Duration of headache	48 hours n=109 Participants	72 hours n=111 Participants	72 hours n=220 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=101 Participants Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental n=106 Participants Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Headache Days as Self-reported by Participants	3.0 days Interval 2.5 to 3.5	3.3 days Interval 2.8 to 3.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=107 Participants Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental n=110 Participants Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Number of Participants With Sustained Headache Freedom	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Control n=101 Participants Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental n=106 Participants Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Medication Preference as Assessed by Self-report	76 Participants	75 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=109 participants at risk Metoclopramide 10mg IV+ dexamethasone 10mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes Dexamethasone: dexamethasone 10mg intramuscular injection	Experimental n=111 participants at risk Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM metoclopramide: metoclopramide 10mg intravenous infusion over 15 minutes methylprednisolone acetate: methylprednislone acetate 160mg intramuscular injection
Nervous system disorders Akathisia	1.8% 2/109 • Number of events 2 • 1 week	6.3% 7/111 • Number of events 7 • 1 week
Skin and subcutaneous tissue disorders Injection site reaction	0.92% 1/109 • Number of events 1 • 1 week	8.1% 9/111 • Number of events 9 • 1 week

Additional Information

Benjamin W. Friedman, MD

Montefiore Health

Phone: 17189206626

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place