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Olanzapine for Acute Headaches (Olanzapine)

This study is currently recruiting participants.
Verified December 2016 by HealthPartners Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03066622
First Posted: February 28, 2017
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HealthPartners Institute
  Purpose
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.

Condition Intervention
Headache Drug: Standard of Care as per attending physician Drug: 5mg rapidly dissolving olanzapine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Change in pain scores based on patient questionnaire [ Time Frame: 30 and 60 minutes post drug ingestion ]
    relief of primary acute headache


Secondary Outcome Measures:
  • Comparison of duration of ED length of stay [ Time Frame: Length of Emergency Department stay (Time Frame: up to 12 hours) ]
    Comparison of duration of ED length of stay when compared to current standard of care

  • 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


Estimated Enrollment: 124
Actual Study Start Date: July 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Zydis

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066622


Contacts
Contact: Bradley Hernandez, MD 651-254-3108 bradley.s.hernandez@healthpartners.com
Contact: Sandi S Wewerka, MPH 651-254-5304 sandi.s.wewerka@healthpartneres.com

Locations
United States, Minnesota
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Bradley S Hernandez, MD    651-254-3108    bradley.s.hernandez@healthpartners.com   
Contact: Sandi S Wewerka, MPH    651-254-5304    sandi.s.wewerka@healthpartners.com   
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: Bradley Hernandez, MD HealthPartners Institute
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03066622     History of Changes
Other Study ID Numbers: 16-420
First Submitted: December 6, 2016
First Posted: February 28, 2017
Last Update Posted: August 4, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents