Trial Outcomes & Findings for Olanzapine for Acute Headaches (NCT NCT03066622)
NCT ID: NCT03066622
Last Updated: 2022-01-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
baseline, 30, 60, and 90 minutes post drug administration
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
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)
|
Olanzapine
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
26
|
26
|
Reasons for withdrawal
| Measure |
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)
|
Olanzapine
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
25
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Olanzapine for Acute Headaches
Baseline characteristics by cohort
| Measure |
Standard of Care
n=60 Participants
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)
|
Olanzapine
n=59 Participants
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 30, 60, and 90 minutes post drug administrationPopulation: 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.
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.
Outcome measures
| Measure |
Standard of Care
n=58 Participants
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)
|
Olanzapine
n=56 Participants
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
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
|
-1.79 units on a scale of 1-10
Standard Deviation 1.83
|
|
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
|
-2.65 units on a scale of 1-10
Standard Deviation 2.36
|
|
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
|
-3.88 units on a scale of 1-10
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: 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.
The total time the patient spent in the ED after initially being seen by the physician
Outcome measures
| Measure |
Standard of Care
n=60 Participants
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)
|
Olanzapine
n=58 Participants
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
Comparison of Duration of ED Length of Stay
|
179.57 Minutes
Standard Deviation 83.67
|
180.28 Minutes
Standard Deviation 78.60
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Standard of Care
n=60 Participants
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)
|
Olanzapine
n=58 Participants
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
Number of Participants That Receive Peripheral Intravenous Catheterization
|
55 Participants
|
28 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Olanzapine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=60 participants at risk
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)
|
Olanzapine
n=59 participants at risk
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
5mg rapidly dissolving olanzapine: 5mg rapidly dissolving olanzapine
|
|---|---|---|
|
General disorders
Dizziness, lightheadedness
|
6.7%
4/60 • Number of events 4 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
3.4%
2/59 • Number of events 2 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
|
General disorders
Drowsiness
|
3.3%
2/60 • Number of events 2 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
10.2%
6/59 • Number of events 6 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Number of events 2 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
|
Injury, poisoning and procedural complications
Burning sensation at IV site
|
3.3%
2/60 • Number of events 2 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
0.00%
0/59 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
|
Ear and labyrinth disorders
Ringing in ears
|
0.00%
0/60 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
|
General disorders
Jittery feeling
|
3.3%
2/60 • Number of events 2 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected until completion of the 48 hour follow-up phone call (24-72 hours following enrollment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place