Olanzapine for Acute Headaches

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Headache

Intervention / Treatment
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* Drug: Standard of Care as per attending physician
* Drug: 5mg rapidly dissolving olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient between 18-65 years of age presenting to the emergency department with acute primary headache Patient approved for inclusion by primary attending physician in the emergency department Exclusion Criteria: Age < 18 or > 65 Pregnancy Known allergy to olanzapine Known QT prolongation or underlying condition that places patient at risk for QT prolongation Inability to give written consent (intoxication, altered mental status) Headache of organic origin (trauma, infection, previous recent head or neck surgery) Patient already prescribed daily olanzapine on an outpatient basis Patient has been administered olanzapine within the past 24 hours Language barrier

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>IV Morphine or any medication per attending decision | Drug: Standard of Care as per attending physician<br>* Patients are randomized to standard of care medication (as determined by attending physician)<br>* Other names: standard of care;|
| Experimental: Olanzapine<br>oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. | Drug: 5mg rapidly dissolving olanzapine<br>* 5mg rapidly dissolving olanzapine<br>* Other names: Zydis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Scores Based on Patient Questionnaire | Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable. | baseline, 30, 60, and 90 minutes post drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Duration of ED Length of Stay | The total time the patient spent in the ED after initially being seen by the physician | Length of Emergency Department stay (Time Frame: up to 12 hours) | 
| Number of Participants That Receive Peripheral Intravenous Catheterization | Determining if patients randomized to rapidly dissolving Olanzapine eventually require IV access, defined as A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture | Length of Emergency Department stay (Time Frame: up to 12 hours) |