Olanzapine for Acute Headaches (Olanzapine)

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

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.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Drug: Standard of Care as per attending physician; Drug: 5mg rapidly dissolving olanzapine

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard of Care; IV Morphine or any medication per attending decision	Drug: Standard of Care as per attending physician; Patients are randomized to standard of care medication (as determined by attending physician); Other Names: standard of care
EXPERIMENTAL: Olanzapine; oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.	Drug: 5mg rapidly dissolving olanzapine; 5mg rapidly dissolving olanzapine; Other Names: Zydis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Bradley Hernandez, MD, HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): May 17, 2018
• Study Completion (ACTUAL): May 20, 2018

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: 16-420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO