Trial Outcomes & Findings for Oral Dexamethasone for Treatment of Migraine (NCT NCT00216736)

Results Overview

Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

48 hours

Results posted on

2015-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo	Dexamethasone
Overall Study STARTED	32	31
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	Dexamethasone
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Oral Dexamethasone for Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=32 Participants	Dexamethasone n=31 Participants	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 13 • n=5 Participants	37 years STANDARD_DEVIATION 11 • n=7 Participants	39 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Australia	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants	Dexamethasone n=30 Participants
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.	13 Participants	14 Participants

PRIMARY outcome

Timeframe: 48 hours

Proportion of patients who report recurrent headache within 48 hours, on telephone followup.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants	Dexamethasone n=30 Participants
Proportion of Patients With Recurrent Headache Within 48 Hours.	12 Partcipants	8 Partcipants

SECONDARY outcome

Timeframe: 48 hours

Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants	Dexamethasone n=30 Participants
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.	19 Participants	18 Participants

POST_HOC outcome

Timeframe: 48 hours

Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants	Dexamethasone n=20 Participants
Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours	9 Participants	3 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=32 participants at risk	Dexamethasone n=31 participants at risk
Gastrointestinal disorders Nausea	0.00% 0/32	3.2% 1/31 • Number of events 1
Vascular disorders flushing	0.00% 0/32	6.5% 2/31 • Number of events 2
Nervous system disorders tingling	0.00% 0/32	6.5% 2/31 • Number of events 2
Eye disorders blurred vision	0.00% 0/32	3.2% 1/31 • Number of events 1
Gastrointestinal disorders diarrhoea	0.00% 0/32	3.2% 1/31 • Number of events 1

Additional Information

Prof Anne-Maree Kelly

Joseph Epstein Centre for Emergency Medicine Research

Phone: +61383456666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place