Olanzapine for Acute Headaches



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:6/9/2018
Start Date:July 2016
End Date:May 20, 2018

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Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial

This trial is a prospective, randomized, feasibility trial with the primary aim of comparing
how well oral rapidly dissolving olanzapine controls primary headache pain when compared to
the current treatment strategies used in emergency departments which often require
intravenous or intramuscular medications.

Primary Question:

Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute
headache of non-organic origin (primary headache) who come to the ED for abortive therapy
when compared to current standard of care?

Secondary Aim:

Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1)
duration of ED length of stay and 2) need for IV access when compared to the current standard
of care.

This is a prospective, randomized, convenience sample, feasibility trial to test for
non-inferiority of oral rapidly dissolving olanzapine versus current emergency department
standard of care in providing symptomatic relief to patients presenting with primary
headache.

Inclusion Criteria:

1. Adult patient between 18-65 years of age presenting to the emergency department with
acute primary headache

2. Patient approved for inclusion by primary attending physician in the emergency
department

Exclusion Criteria:

1. Age < 18 or > 65

2. Pregnancy

3. Known allergy to olanzapine

4. Known QT prolongation or underlying condition that places patient at risk for QT
prolongation

5. Inability to give written consent (intoxication, altered mental status)

6. Headache of organic origin (trauma, infection, previous recent head or neck surgery)

7. Patient already prescribed daily olanzapine on an outpatient basis

8. Patient has been administered olanzapine within the past 24 hours

9. Language barrier
We found this trial at
1
site
640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
Phone: 651-254-3108
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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mi
from
Saint Paul, MN
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