Olanzapine for Acute Headaches

NCT ID: NCT03066622

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-05-20

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.

Conditions

Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

IV Morphine or any medication per attending decision

Group Type: ACTIVE_COMPARATOR

Standard of Care as per attending physician

Intervention Type: DRUG

Patients are randomized to standard of care medication (as determined by attending physician)

Olanzapine

oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.

Group Type: EXPERIMENTAL

5mg rapidly dissolving olanzapine

Intervention Type: DRUG

5mg rapidly dissolving olanzapine

Interventions

Standard of Care as per attending physician

Patients are randomized to standard of care medication (as determined by attending physician)

Intervention Type: DRUG

5mg rapidly dissolving olanzapine

5mg rapidly dissolving olanzapine

Intervention Type: DRUG

Other Intervention Names

standard of care; Zydis

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-420

Identifier Type: -

Identifier Source: org_study_id