Trial Outcomes & Findings for Aspirin for Treatment of Multiple Sclerosis-Related Fatigue (NCT NCT00467584)
NCT ID: NCT00467584
Last Updated: 2014-05-20
Results Overview
The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2014-05-20
Participant Flow
Participants with Multiple Sclerosis were recruited from three Mayo Clinic sites (Arizona, Minnesota and Florida) beginning in July, 2007.
Participant milestones
| Measure |
High Dose Aspirin
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
|
Low Dose Aspirin
Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
|
Placebo
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
|
Overall Study
COMPLETED
|
17
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
1
|
Reasons for withdrawal
| Measure |
High Dose Aspirin
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
|
Low Dose Aspirin
Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks
|
Placebo
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
1
|
Baseline Characteristics
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Baseline characteristics by cohort
| Measure |
High Dose Aspirin
n=21 Participants
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
|
Low Dose Aspirin
n=20 Participants
Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
|
Placebo
n=21 Participants
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: 62 patients were randomized; of these, 6 did not receive the intervention and an additional 4 discontinued without providing followup data. Therefore 52 were included in the analysis. The Wk 4 MFIS score was used if the subject withdrew prior to Wk 8. 1 subject each in the High Dose and Placebo groups provided MFIS data at Wk 4 but not Wk 8.
The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.
Outcome measures
| Measure |
High Dose Aspirin
n=17 Participants
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
|
Low Dose Aspirin
n=15 Participants
Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
|
Placebo
n=20 Participants
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
|
|---|---|---|---|
|
Modified Fatigue Impact Scale Score
MFIS Total Score at Baseline
|
48 units on a scale
Standard Deviation 13
|
50 units on a scale
Standard Deviation 15
|
49 units on a scale
Standard Deviation 13
|
|
Modified Fatigue Impact Scale Score
MFIS Total Score at 8 Weeks
|
37 units on a scale
Standard Deviation 11
|
45 units on a scale
Standard Deviation 17
|
44 units on a scale
Standard Deviation 13
|
|
Modified Fatigue Impact Scale Score
Change in MFIS Total Score
|
-11.4 units on a scale
Standard Deviation 13.9
|
-5.1 units on a scale
Standard Deviation 15.7
|
-5.5 units on a scale
Standard Deviation 9.8
|
Adverse Events
High Dose Aspirin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Low Dose Aspirin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Aspirin
n=17 participants at risk
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
|
Low Dose Aspirin
n=15 participants at risk
Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
|
Placebo
n=20 participants at risk
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
0.00%
0/20 • Baseline to 8 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Number of events 2 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
0.00%
0/20 • Baseline to 8 weeks
|
|
Gastrointestinal disorders
Pharyngitis
|
5.9%
1/17 • Number of events 1 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
0.00%
0/20 • Baseline to 8 weeks
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
5.9%
1/17 • Number of events 1 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
0.00%
0/20 • Baseline to 8 weeks
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/17 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 8 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/17 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 8 weeks
|
|
Skin and subcutaneous tissue disorders
Nevus removal
|
0.00%
0/17 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Baseline to 8 weeks
|
0.00%
0/15 • Baseline to 8 weeks
|
0.00%
0/20 • Baseline to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place