Clinical trial NCT03066622: Olanzapine for Acute Headaches
Official title: Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Scores Based on Patient Questionnaire
timeFrame: baseline, 30, 60, and 90 minutes post drug administration
Secondary outcomes:
measure: Comparison of Duration of ED Length of Stay
timeFrame: Length of Emergency Department stay (Time Frame: up to 12 hours)
measure: Number of Participants That Receive Peripheral Intravenous Catheterization
timeFrame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Bradley Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: