Trial Outcomes & Findings for Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines (NCT NCT00122278)

NCT ID: NCT00122278

Last Updated: 2018-11-13

Results Overview

Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 205 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2018-11-13

Participant Flow

Participant milestones

Measure	Dexamethasone Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV
Overall Study STARTED	106	99
Overall Study COMPLETED	104	99
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Dexamethasone Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dexamethasone n=106 Participants Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo n=99 Participants Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV	Total n=205 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=106 Participants	37 years STANDARD_DEVIATION 11 • n=99 Participants	37 years STANDARD_DEVIATION 10 • n=205 Participants
Sex: Female, Male Female	87 Participants n=106 Participants	87 Participants n=99 Participants	174 Participants n=205 Participants
Sex: Female, Male Male	19 Participants n=106 Participants	12 Participants n=99 Participants	31 Participants n=205 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	106 Participants n=106 Participants	99 Participants n=99 Participants	205 Participants n=205 Participants
Duration of headache Prior to Study	48 hours n=106 Participants	48 hours n=99 Participants	48 hours n=205 Participants

PRIMARY outcome

Timeframe: 24 hours

Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge

Outcome measures

Measure	Dexamethasone n=104 Participants Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo n=99 Participants Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV
Persistent Headache Pain Free at 24 Hours	26 Participants	19 Participants

SECONDARY outcome

Timeframe: 24 hours

No functional impairment within 24 hours of emergency department discharge

Outcome measures

Measure	Dexamethasone n=104 Participants Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo n=99 Participants Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV
Functional Disability at 24 Hours	70 Participants	55 Participants

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dexamethasone n=106 participants at risk Dexamethasone 10 mg Dexamethasone: Dexamethasone 10mg IV	Placebo n=99 participants at risk Placebo Dexamethasone, 10 mg Placebo: Placebo Dexamethasone 10mg IV
Nervous system disorders Drowsiness	17.9% 19/106 • Number of events 19	11.1% 11/99 • Number of events 11
General disorders Dizziness	2.8% 3/106 • Number of events 3	2.0% 2/99 • Number of events 2
General disorders Acute Medication Reactoin	9.4% 10/106 • Number of events 10	2.0% 2/99 • Number of events 2
General disorders Other	8.5% 9/106 • Number of events 9	12.1% 12/99 • Number of events 12

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: (718)920-6266

Email: befriedm@montefiore.org

Results disclosure agreements

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