HeadachePhase 4OlanzapineNCT03066622
Olanzapine for Acute Headaches
A Phase 4 study testing 5mg rapidly dissolving olanzapine in people with Headache, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- 5mg rapidly dissolving olanzapine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 20 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Patient already prescribed daily olanzapine on an outpatient basis
- Patient has been administered olanzapine within the past 24 hours
- Language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
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.
Read the 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.
- Conditions
- Headache
- Being tested
- Standard of Care as per attending physician, 5mg rapidly dissolving olanzapine
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care as per attending physicianDrug
Also called standard of care
Patients are randomized to standard of care medication (as determined by attending physician)
5mg rapidly dissolving olanzapineDrug
Also called Zydis
5mg rapidly dissolving olanzapine
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | IV Morphine or any medication per attending decision Receives: Drug: Standard of Care as per attending physician |
| Olanzapine | Experimental | oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. Receives: Drug: 5mg rapidly dissolving olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 30, 60, and 90 minutes post drug administration
Secondary outcomes (2)
Comparison of Duration of ED Length of Stay
The total time the patient spent in the ED after initially being seen by the physician
Measured: Length of Emergency Department stay (Time Frame: up to 12 hours)
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
Measured: Length of Emergency Department stay (Time Frame: up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startJul 2016
- Primary completion17 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Hernandez, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066622
- Sponsor's protocol ID
- 16-420
- Acronym
- Olanzapine
- Status last verified
- Jun 2018
- First submitted
- 6 Dec 2016
- Last updated
- 12 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03066622
- Acronym / sponsor ID
- Olanzapine / 16-420
- Conditions
- Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Standard of Care as per attending physicianIV Morphine or any medication per attending decision |
| Olanzapine | Experimental | Drug: 5mg rapidly dissolving olanzapineoral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care as per attending physicianAlso: standard of carePatients are randomized to standard of care medication (as determined by attending physician) | Drug | Standard of Care |
| 5mg rapidly dissolving olanzapineAlso: Zydis5mg rapidly dissolving olanzapine | Drug | Olanzapine |
Primary outcome
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.
2 secondary outcomes
Comparison of Duration of ED Length of Stay
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Number of Participants That Receive Peripheral Intravenous Catheterization
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Hernandez, MD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5mg rapidly dissolving olanzapine in people with Headache, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Scores Based on Patient Questionnaire (time frame: baseline, 30, 60, and 90 minutes post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.