Trial Outcomes & Findings for Aspirin as a Pre-Treatment for Exercise in Multiple Sclerosis (NCT NCT03051646)

Last Updated: 2018-11-20

Results Overview

The measure of interest is the length of time (in seconds) spent exercising at each session. This time has no pre-set upper limit, i.e. patients are free to exercise as long as they wish. This means that the time will not be censored. However, please note that healthy adults' time to exhaustion is approximately 12 minutes.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.

Results posted on

2018-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Acetylsalicylic Acid at 1st Visit Then Placebo at 2nd Visit Within-subjects design Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise First intervention: 1 day; washout period: 1 week; second intervention: 1 day	Placebo at 1st Visit Then Acetylsalicylic Acid at 2nd Visit Within-subjects design Participant is administered placebo one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise First intervention: 1 day; washout period: 1 week; second intervention: 1 day
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetylsalicylic Acid at 1st Visit, Then Placebo at 2nd Visit n=6 Participants Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise	Placebo at 1st Visit, Then Acetylsalicylic Acid at 2nd Visit n=6 Participants Participant is administered placebo one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise	Total n=12 Participants Total of all reporting groups
Age, Categorical Overall Participants · <=18 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Age, Categorical Overall Participants · Between 18 and 65 years	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants
Age, Categorical Overall Participants · >=65 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	4 Participants n=6 Participants	8 Participants n=12 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	2 Participants n=6 Participants	4 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants
Self-report heat-sensitivity during exercise	5 Participants n=6 Participants	3 Participants n=6 Participants	8 Participants n=12 Participants

PRIMARY outcome

Timeframe: ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.

Population: All participants were recruited from the Columbia MS Center for Research and Treatment in New York, New York.

Outcome measures

Outcome measures
Measure	Acetylsalicylic Acid n=12 Participants Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise	Placebo Oral Capsule n=12 Participants Participant is administered placebo one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise
Change in Time to Exhaustion	568 seconds Standard Deviation 150	552 seconds Standard Deviation 152

SECONDARY outcome

Timeframe: Effect of treatment on body temperature in a single session (i.e., pre- to post- exercise test) to be completed within a 14-day period

Population: subsample of people who self- identified as heat-sensitive during exercise (n=8)

Measure of interest is increase in body temperature from pre- to post-exercise test in each treatment condition (ASA vs. placebo)

Outcome measures

Outcome measures
Measure	Acetylsalicylic Acid n=8 Participants Participant is administered acetylsalicylic acid, an intervention to improve exercise performance (i.e., increase time to exhaustion) one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise	Placebo Oral Capsule n=8 Participants Participant is administered placebo one hour prior to exercise. Acetylsalicylic acid: 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise Placebo Oral capsule: Placebo capsule is administered one hour prior to exercise
Exercise-induced Body Temperature Increase	0.41 degrees Fahrenheit Standard Deviation 0.55	0.88 degrees Fahrenheit Standard Deviation 0.63

Adverse Events

Acetylsalicylic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Oral Capsule

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

Columbia University Medical Center

Phone: 212 342 1351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place