search
Back to results

Olanzapine for Acute Headaches (Olanzapine)

Primary Purpose

Headache

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard of Care as per attending physician
5mg rapidly dissolving olanzapine
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Regions Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Olanzapine

Arm Description

IV Morphine or any medication per attending decision

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of Duration of ED Length of Stay
The total time the patient spent in the ED after initially being seen by the physician
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

Full Information

First Posted
December 6, 2016
Last Updated
January 2, 2022
Sponsor
HealthPartners Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03066622
Brief Title
Olanzapine for Acute Headaches
Acronym
Olanzapine
Official Title
Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
May 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Open label, not blinded, randomized 2-arm trial
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
IV Morphine or any medication per attending decision
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
Intervention Type
Drug
Intervention Name(s)
Standard of Care as per attending physician
Other Intervention Name(s)
standard of care
Intervention Description
Patients are randomized to standard of care medication (as determined by attending physician)
Intervention Type
Drug
Intervention Name(s)
5mg rapidly dissolving olanzapine
Other Intervention Name(s)
Zydis
Intervention Description
5mg rapidly dissolving olanzapine
Primary Outcome Measure Information:
Title
Change in Pain Scores Based on Patient Questionnaire
Description
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.
Time Frame
baseline, 30, 60, and 90 minutes post drug administration
Secondary Outcome Measure Information:
Title
Comparison of Duration of ED Length of Stay
Description
The total time the patient spent in the ED after initially being seen by the physician
Time Frame
Length of Emergency Department stay (Time Frame: up to 12 hours)
Title
Number of Participants That Receive Peripheral Intravenous Catheterization
Description
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
Time Frame
Length of Emergency Department stay (Time Frame: up to 12 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 < 18 or > 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Hernandez, MD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Olanzapine for Acute Headaches

We'll reach out to this number within 24 hrs