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Trial record 1 of 2 for:    multiple sclerosis aspirin
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Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

This study has been terminated.
(Interim analysis indicated treatment unlikely effective;slow recruitment)
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00467584
First received: April 26, 2007
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with Multiple Sclerosis were recruited from three Mayo Clinic sites (Arizona, Minnesota and Florida) beginning in July, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    High Dose Aspirin     Low Dose Aspirin     Placebo  
STARTED     21     20     21  
COMPLETED     17     15     20  
NOT COMPLETED     4     5     1  
Withdrawal by Subject                 4                 5                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Aspirin High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
Low Dose Aspirin Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
Placebo Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
Total Total of all reporting groups

Baseline Measures
    High Dose Aspirin     Low Dose Aspirin     Placebo     Total  
Number of Participants  
[units: participants]
  21     20     21     62  
Age  
[units: years]
Mean ± Standard Deviation
  46.6  ± 8.6     47.0  ± 10.3     47.4  ± 8.0     47.0  ± 9.0  
Gender  
[units: participants]
       
Female     17     15     18     50  
Male     4     5     3     12  
Region of Enrollment  
[units: participants]
       
United States     21     20     21     62  



  Outcome Measures

1.  Primary:   Modified Fatigue Impact Scale Score   [ Time Frame: Baseline, 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to smaller number of subjects analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Dean M. Wingerchuk
Organization: Mayo Clinic
phone: 480-301-6328
e-mail: wingerchuk.dean@mayo.edu


No publications provided


Responsible Party: Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00467584     History of Changes
Other Study ID Numbers: 06-004850
Study First Received: April 26, 2007
Results First Received: April 17, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board