NCT03066622

Olanzapine for Acute Headaches

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Headache

Interventions

Type	Name	Description
DRUG	Standard of Care as per attending physician	Patients are randomized to standard of care medication (as determined by attending physician)
DRUG	5mg rapidly dissolving olanzapine	5mg rapidly dissolving olanzapine

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-05-17
• Completion: 2018-05-20
• First posted: 2017-02-28
• Last updated: 2022-01-12
• Results posted: 2019-08-20

Locations

1 site across 1 country: United States