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Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

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ClinicalTrials.gov Identifier: NCT00467584
Recruitment Status : Terminated (Interim analysis indicated treatment unlikely effective;slow recruitment)
First Posted : April 30, 2007
Results First Posted : May 16, 2014
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Fatigue
Interventions Drug: High Dose Aspirin (1300 mg/day)
Drug: Low Dose Aspirin (162 mg/day)
Drug: Placebo
Enrollment 62
Recruitment Details Participants with Multiple Sclerosis were recruited from three Mayo Clinic sites (Arizona, Minnesota and Florida) beginning in July, 2007.
Pre-assignment Details  
Arm/Group Title High Dose Aspirin Low Dose Aspirin Placebo
Hide Arm/Group Description

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; 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 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

Period Title: Overall Study
Started 21 20 21
Completed 17 15 20
Not Completed 4 5 1
Reason Not Completed
Withdrawal by Subject             4             5             1
Arm/Group Title High Dose Aspirin Low Dose Aspirin Placebo Total
Hide Arm/Group Description High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 20 21 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 21 participants 62 participants
46.6  (8.6) 47.0  (10.3) 47.4  (8.0) 47.0  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 21 participants 62 participants
Female
17
  81.0%
15
  75.0%
18
  85.7%
50
  80.6%
Male
4
  19.0%
5
  25.0%
3
  14.3%
12
  19.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 21 participants 62 participants
21 20 21 62
1.Primary Outcome
Title Modified Fatigue Impact Scale Score
Hide Description 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.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Dose Aspirin Low Dose Aspirin Placebo
Hide Arm/Group Description:
High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
Overall Number of Participants Analyzed 17 15 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
MFIS Total Score at Baseline 48  (13) 50  (15) 49  (13)
MFIS Total Score at 8 Weeks 37  (11) 45  (17) 44  (13)
Change in MFIS Total Score -11.4  (13.9) -5.1  (15.7) -5.5  (9.8)
Time Frame Baseline to 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Aspirin Low Dose Aspirin Placebo
Hide Arm/Group Description High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
All-Cause Mortality
High Dose Aspirin Low Dose Aspirin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Aspirin Low Dose Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/15 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Aspirin Low Dose Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/17 (29.41%)      0/15 (0.00%)      3/20 (15.00%)    
Eye disorders       
Conjunctivitis   0/17 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders       
Dyspepsia   2/17 (11.76%)  2 0/15 (0.00%)  0 0/20 (0.00%)  0
Pharyngitis   1/17 (5.88%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Vomiting   1/17 (5.88%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
General disorders       
Fever   1/17 (5.88%)  1 0/15 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders       
Leg pain   0/17 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders       
Hemorrhagic cystitis  [1]  1/17 (5.88%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash   1/17 (5.88%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Nevus removal  [2]  0/17 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
Bladder infection
[2]
Mole removed
Early termination leading to smaller number of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dean M. Wingerchuk
Organization: Mayo Clinic
Phone: 480-301-6328
EMail: wingerchuk.dean@mayo.edu
Layout table for additonal information
Responsible Party: Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00467584     History of Changes
Other Study ID Numbers: 06-004850
First Submitted: April 26, 2007
First Posted: April 30, 2007
Results First Submitted: April 17, 2014
Results First Posted: May 16, 2014
Last Update Posted: May 20, 2014