Olanzapine for Acute Headaches

Headache Clinical Trial

— Olanzapine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066622
• Other study ID #: 16-420
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: May 20, 2018

Study information

• Verified date: June 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 20, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Standard of Care as per attending physician
Patients are randomized to standard of care medication (as determined by attending physician)
• 5mg rapidly dissolving olanzapine
5mg rapidly dissolving olanzapine

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)