Trial Outcomes & Findings for Prospective ED Headache Cohort Study (NCT NCT00313703)

Results Overview

Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain

Recruitment status

COMPLETED

Target enrollment

477 participants

Primary outcome timeframe

24 hours after Emergency Department (ED) discharge

Results posted on

2018-05-15

Participant Flow

We enrolled adult patients who presented to one urban emergency department (ED) with a chief complaint of headache.Patients were assigned a headache diagnosis based on criteria established by the International Headache Society (These are available at http://217.174.249.183/upload/CT\_Clas/ICHD-IIR1final.pdf)

477 patients underwent a detailed interview in the ED. 309 of these patients were determined to have a primary headache disorder (a benign recurrent headache disease) and were entered into the post-ED follow-up portion of this cohort study.

Participant milestones

Participant milestones
Measure	Migraine met International Headache Society migraine criteria	Tension-type Headache met International Headache Society tension-type headache criteria	Unclassifiable Had recurrent headache disorder but did not meet any International Headache Society criteria	Other Met other International Headache Society criteria
Overall Study STARTED	186	34	77	12
Overall Study COMPLETED	175	32	72	0
Overall Study NOT COMPLETED	11	2	5	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Migraine met International Headache Society migraine criteria	Tension-type Headache met International Headache Society tension-type headache criteria	Unclassifiable Had recurrent headache disorder but did not meet any International Headache Society criteria	Other Met other International Headache Society criteria
Overall Study Lost to Follow-up	11	2	5	12

Baseline Characteristics

Prospective ED Headache Cohort Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Migraine n=186 Participants met International Headache Society migraine criteria	Tension-type Headache n=34 Participants met International Headache Society tension-type headache criteria	Unclassifiable n=77 Participants Had recurrent headache disorder but did not meet any International Headache Society criteria	Other n=12 Participants Met other International Headache Society criteria	Total n=309 Participants Total of all reporting groups
Age, Continuous	38 Years STANDARD_DEVIATION 12 • n=5 Participants	40 Years STANDARD_DEVIATION 12 • n=7 Participants	42 Years STANDARD_DEVIATION 12 • n=5 Participants	40 Years STANDARD_DEVIATION 11 • n=4 Participants	39 Years STANDARD_DEVIATION 12 • n=21 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants	8 Participants n=4 Participants	256 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants	4 Participants n=4 Participants	53 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 hours after Emergency Department (ED) discharge

Population: A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.

Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain

Outcome measures

Outcome measures
Measure	Migraine n=172 Participants met International Headache Society migraine criteria	Tension-type Headache n=32 Participants met International Headache Society tension-type headache criteria	Unclassifiable n=75 Participants Had recurrent headache disorder but did not meet any International Headache Society criteria	Other Met other International Headache Society criteria
Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge	53 Participants	6 Participants	20 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.

Headache disability scores. On the MIDAS scale, a score \> five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.

Outcome measures

Outcome measures
Measure	Migraine n=175 Participants met International Headache Society migraine criteria	Tension-type Headache n=32 Participants met International Headache Society tension-type headache criteria	Unclassifiable n=72 Participants Had recurrent headache disorder but did not meet any International Headache Society criteria	Other Met other International Headache Society criteria
Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal	65 participants	12 participants	19 participants	—

Adverse Events

Migraine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tension-type Headache

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unclassifiable

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Other

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin Friedman

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place