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Olanzapine for Acute Headaches (Olanzapine)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03066622
Recruitment Status : Completed
First Posted : February 28, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

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.

Condition or disease Intervention/treatment Phase
Headache Drug: Standard of Care as per attending physician Drug: 5mg rapidly dissolving olanzapine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : May 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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


Locations
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United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Bradley Hernandez, MD HealthPartners Institute
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03066622    
Other Study ID Numbers: 16-420
First Posted: February 28, 2017    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
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