Phase 4
N=122
Olanzapine for Acute Headaches
Headache
Bottom Line
View on ClinicalTrials.gov: NCT03066622 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change in Pain Scores Based on Patient Questionnaire — -2.95; -1.79; -4.49; -2.65 units on a scale of 1-10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standard of Care as per attending physician (Drug); 5mg rapidly dissolving olanzapine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores Based on Patient Questionnaire |
-2.95; -1.79; -4.49; -2.65; -4.68; -3.88 | — |
| SECONDARY Comparison of Duration of ED Length of Stay |
179.57; 180.28 | — |
| SECONDARY Number of Participants That Receive Peripheral Intravenous Catheterization |
55; 28 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03066622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.