Headache
Conditions
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.
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.
Interventions
DRUGStandard of Care as per attending physician
Patients are randomized to standard of care medication (as determined by attending physician)
DRUG5mg rapidly dissolving olanzapine
5mg rapidly dissolving olanzapine
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label, not blinded, randomized 2-arm trial
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores Based on Patient Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Duration of ED Length of Stay | 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 |
| Number of Participants That Receive Peripheral Intravenous Catheterization | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of Care medication for treatment of headache as per attending physician: Patients are randomized to standard of care medication (as determined by attending physician) | 60 |
| Olanzapine oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine | 59 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 24 | 25 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Olanzapine |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 11.2 | 34.2 years STANDARD_DEVIATION 10.8 | 34.2 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 110 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 49 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 57 Participants | 28 Participants |
| Region of Enrollment United States | 60 participants | 119 participants | 59 participants |
| Sex: Female, Male Female | 47 Participants | 89 Participants | 42 Participants |
| Sex: Female, Male Male | 13 Participants | 30 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 12 / 60 | 11 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
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.
Time frame: baseline, 30, 60, and 90 minutes post drug administration
Population: Not all participants were assessed at each time point due to some being discharged from the Emergency Department prior to study data collection time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change in Pain Scores Based on Patient Questionnaire | Pain at 60 minutes | -4.49 units on a scale of 1-10 | Standard Deviation 2.95 |
| Standard of Care | Change in Pain Scores Based on Patient Questionnaire | Pain at 90 minutes | -4.68 units on a scale of 1-10 | Standard Deviation 2.64 |
| Standard of Care | Change in Pain Scores Based on Patient Questionnaire | Pain at 30 minutes | -2.95 units on a scale of 1-10 | Standard Deviation 2.5 |
| Olanzapine | Change in Pain Scores Based on Patient Questionnaire | Pain at 30 minutes | -1.79 units on a scale of 1-10 | Standard Deviation 1.83 |
| Olanzapine | Change in Pain Scores Based on Patient Questionnaire | Pain at 60 minutes | -2.65 units on a scale of 1-10 | Standard Deviation 2.36 |
| Olanzapine | Change in Pain Scores Based on Patient Questionnaire | Pain at 90 minutes | -3.88 units on a scale of 1-10 | Standard Deviation 2.79 |
Secondary
Comparison of Duration of ED Length of Stay
The total time the patient spent in the ED after initially being seen by the physician
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Population: Data was only available for 60 subjects in the standard of care arm and 58 subjects in the olanzapine arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Comparison of Duration of ED Length of Stay | 179.57 Minutes | Standard Deviation 83.67 |
| Olanzapine | Comparison of Duration of ED Length of Stay | 180.28 Minutes | Standard Deviation 78.6 |
Secondary
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
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)
Population: Subjects consenting to participate in the study through time of ED discharge with complete data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants That Receive Peripheral Intravenous Catheterization | 55 Participants |
| Olanzapine | Number of Participants That Receive Peripheral Intravenous Catheterization | 28 Participants |