Trial Outcomes & Findings for Aspirin for Exercise in Multiple Sclerosis (ASPIRE) (NCT NCT03824938)
NCT ID: NCT03824938
Last Updated: 2023-10-27
Results Overview
Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for \>/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
from start of exercise test until self-reported exhaustion, up to 30 minutes
Results posted on
2023-10-27
Participant Flow
Out of the 97 screened, 60 were enrolled in the study.
Out of the 60 enrolled, 37 completed at least one visit.
Participant milestones
| Measure |
Placebo First, Then Aspirin, Then Acetaminophen
First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Placebo First, Then Acetaminophen, Then Aspirin
First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Aspirin First, Then Placebo, Then Acetaminophen
First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Aspirin First, Then Acetaminophen, Then Placebo
First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Acetaminophen First, Then Placebo, Then Aspirin
First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Acetaminophen First, Then Aspirin, Then Placebo
First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
7
|
5
|
7
|
3
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo First, Then Aspirin, Then Acetaminophen
First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Placebo First, Then Acetaminophen, Then Aspirin
First session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Aspirin First, Then Placebo, Then Acetaminophen
First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Aspirin First, Then Acetaminophen, Then Placebo
First session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Acetaminophen First, Then Placebo, Then Aspirin
First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
|
Acetaminophen First, Then Aspirin, Then Placebo
First session: Acetaminophen 650 mg capsule by mouth, single dose. A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
Second session: Aspirin 650 mg capsule by mouth, single dose. A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
Third session: Placebo 650 mg capsule by mouth, single dose. A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Baseline characteristics by cohort
| Measure |
All Participants
n=37 Participants
ASPIRE trial sample characteristics of the 37 active study participants.
|
|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutesDuration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for \>/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria.
Outcome measures
| Measure |
Acetaminophen
n=32 Participants
Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
Placebo
n=32 Participants
Participants received placebo 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
Aspirin
n=31 Participants
Participants received aspirin 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
|---|---|---|---|
|
Time-to-exhaustion
|
578.2 seconds
Standard Deviation 82.1
|
551.7 seconds
Standard Deviation 78.4
|
331.6 seconds
Standard Deviation 76.6
|
PRIMARY outcome
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutesChange in body temperature from pre- to post- maximal exercise test.
Outcome measures
| Measure |
Acetaminophen
n=32 Participants
Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
Placebo
n=32 Participants
Participants received placebo 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
Aspirin
n=31 Participants
Participants received aspirin 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.
|
|---|---|---|---|
|
Exercise-induced Body Temperature Change
|
0.31 degrees Fahrenheit
Standard Deviation 0.35
|
0.68 degrees Fahrenheit
Standard Deviation 0.35
|
0.006 degrees Fahrenheit
Standard Deviation 0.32
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Victoria M. Leavitt, MD
Columbia University Irving Medical Center
Phone: 212-342-1351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place