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OpenTrials
Completed

NCT Number: NCT03066622

Olanzapine for Acute Headaches

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care as per attending physician

Drug

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

Other names: standard of care

5mg rapidly dissolving olanzapine

Drug

5mg rapidly dissolving olanzapine

Other names: Zydis

Primary outcomes

  1. Change in Pain Scores Based on Patient Questionnaire

    Time frame: baseline, 30, 60, and 90 minutes post drug administration

    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 outcomes

  1. Comparison of Duration of ED Length of Stay

    Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)

    The total time the patient spent in the ED after initially being seen by the physician

  2. Number of Participants That Receive Peripheral Intravenous Catheterization

    Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)

    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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

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

Acronym: Olanzapine

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2017
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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