Olanzapine for Acute Headaches

NCT03066622 | Completed Phase 4 Results

• 1 other identifier: 16-420
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of Duration of ED Length of Stay

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

• Number of Participants That Receive Peripheral Intravenous Catheterization

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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

IV Morphine or any medication per attending decision

Drug: Standard of Care as per attending physician

Olanzapine

EXPERIMENTAL

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

Drug: 5mg rapidly dissolving olanzapine

Interventions

Standard of Care as per attending physician DRUG

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

Also known as: standard of care

Standard of Care

5mg rapidly dissolving olanzapine DRUG

5mg rapidly dissolving olanzapine

Also known as: Zydis

Olanzapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient between 18-65 years of age presenting to the emergency department with acute primary headache

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Headache

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Meghan O'Brien
• Organization: Regions Hospital

meghan.e.obrien@healthpartners.com

651-254-5303

Study Officials

• Bradley Hernandez, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label, not blinded, randomized 2-arm trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 6, 2016
• First Posted: February 28, 2017
• Study Start: July 1, 2016
• Primary Completion: May 17, 2018
• Study Completion: May 20, 2018
• Last Updated: January 12, 2022
• Results First Posted: August 20, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)