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Trial record 74 of 252 for:    ASPIRIN AND low-dose aspirin

Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE April 26, 2007
First Posted Date  ICMJE April 30, 2007
Results First Submitted Date  ICMJE April 17, 2014
Results First Posted Date  ICMJE May 16, 2014
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE July 2007
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
Modified Fatigue Impact Scale Score [ Time Frame: Baseline, 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
Modified Fatigue Impact Scale score at 8 weeks [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00467584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
  • Visual Analog Scale score at 8 weeks [ Time Frame: 8 weeks ]
  • Cognitive fatigue measure at 8 weeks [ Time Frame: 8 weeks ]
  • Motor fatigue measure at 8 weeks [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Official Title  ICMJE Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Brief Summary The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).
Detailed Description

Fatigue is the most common symptom of multiple sclerosis (MS), affecting up to 90% of people with the disease. MS-related fatigue can be disabling even when other features of MS are mild. It can interfere with physical activity, memory and thinking, social and family activities, and ability to work. Initial treatment consists of energy conservation techniques such as rest periods or naps but when these approaches fail doctors usually recommend a trial of medications. Amantadine, modafinil, and other stimulants are commonly used but help only about half of those who try them. It is unlikely that these drugs directly affect the cause of MS-related fatigue.

It has been difficult to develop new drug therapies for MS-related fatigue because we do not fully understand its causes and do not have precise ways to measure it. We rely on a person's self-report about their fatigue but individuals experience and report fatigue differently. Recent research has shown that some fatigue aspects, such as difficulty maintaining mental concentration ("cognitive fatigue") and physical activity ("motor fatigue"), can be measured more precisely and require further study.

We recently reported results from a study showing that people taking the equivalent of four regular aspirin tablets (1300 mg) daily had reduced MS-related fatigue compared with placebo (sugar pill). The current proposal will attempt to confirm the benefit of aspirin in a larger group of people and to determine if the benefit is related to inflammation. One hundred and thirty-five people with MS-related fatigue will participate at MS clinics at three Mayo Clinic sites. Participants will complete questionnaires that ask about the severity and impact of their fatigue, memory testing to assess cognitive fatigue, and have blood testing to measure markers of inflammation. At the Arizona site, participants will also do strength testing in a motor laboratory to assess motor fatigue. After obtaining two separate baseline evaluations, the participants will be randomly assigned treatment such that one-third will receive 1300 mg per day of aspirin, one-third will receive 162 mg per day of aspirin and one-third will receive a matching placebo. All participants will then return to the clinic on two more occasions over the next eight weeks to repeat the questionnaires, memory and strength testing, blood tests, and report any side-effects. At the end of the study, the results of one of the fatigue questionnaires will be analyzed to determine if aspirin significantly improved fatigue compared with the placebo. The results of other questionnaires and the memory and strength testing will be analyzed as supportive evidence.

If this study is successful, it will provide strong scientific evidence that aspirin helps MS-related fatigue. It will add an important new option for treatment of all MS patients that is also familiar, inexpensive, and has a good long-term safety record. At the same time, it will allow us to better understand the causes of MS-related fatigue and how to measure it more precisely. This information will be extremely useful for development of other therapies in the future.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Fatigue
Intervention  ICMJE
  • Drug: 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
    Other Names:
    • acetylsalicylic acid
    • ASA
    • Aspirin
  • Drug: 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
    Other Names:
    • acetylsalicylic acid
    • ASA
    • Aspirin
  • Drug: Placebo
    Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
Study Arms  ICMJE
  • Active Comparator: High Dose Aspirin
    High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
    Intervention: Drug: High Dose Aspirin (1300 mg/day)
  • Active Comparator: 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
    Intervention: Drug: Low Dose Aspirin (162 mg/day)
  • Placebo Comparator: Placebo
    Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 17, 2014)
62
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2007)
135
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Confirmed relapsing-remitting or secondary progressive multiple sclerosis,
  • Ambulatory for distance of at least 100 meters without gait assistance,
  • Persistent fatigue for at least 8 weeks that is not attributable to causes other than MS, and
  • Will be able to complete questionnaires and cognitive testing.

Exclusion criteria:

  1. Other evident causes for fatigue:

    • Untreated depression or screening Center for Epidemiologic Studies Depression (CES-D) scale greater than 28
    • Significant cognitive impairment (Baseline Short Test of Mental Status score of less than 29/38)
    • Narcolepsy, uncontrolled sleep apnea, or other primary sleep disorder judged to be likely a major contributor to fatigue
    • Screening Epsworth Sleepiness Scale score greater than 15
    • Uncontrolled hypothyroidism or anemia
    • Other medical illness judged by the investigator to affect the participant's fatigue complaints including current viral, bacterial, mycobacterial, or fungal infection
  2. MS Disease Activity and Treatment:

    • Clinical exacerbations within 2 weeks prior to screening visit
    • Corticosteroid use within 4 weeks prior to screening visit
    • Beta-interferon, glatiramer acetate, immunosuppressant drugs (mitoxantrone, azathioprine, etc.) are permitted if a stable dose has been used for greater than or equal to 4 weeks and there is no temporal association of drug administration with perceived fatigue; elective on-study dose/regimen changes are not permitted
  3. Current or Recent Fatigue Therapy and Other Medications:

    • Use of more than two doses of ASA (aspirin) greater than 81 mg/d within 2 weeks of screening visit
    • Use of MS fatigue medications within 2 weeks of screening visit (including amantadine or Central Nervous System stimulants such as modafinil, methylphenidate, and pemoline)
    • Symptomatic medications (antidepressants, anti-spasticity agents, non-narcotic analgesics) are permitted if a stable dose has been used for >4 weeks prior to screening for antidepressants and >2 weeks prior to screening for other symptomatic therapies and there is no temporal association of drug administration with perceived fatigue; elective on-study dose changes are not permitted.
    • Current use of acetazolamide, antiplatelet agents or anticoagulants, COX-2 inhibitors, methotrexate, oral hypoglycemic medications
  4. Medical Contraindications to ASA use:

    • Allergy to ASA or Non-Steroidal Anti-Inflammatory drugs
    • Syndrome of asthma, rhinitis and nasal polyps
    • History of confirmed peptic ulcer or gastrointestinal or severe gynecological bleeding
  5. General Health Concerns:

    • Significant uncontrolled disease of cardiovascular, pulmonary, hepatic, renal, endocrine, rheumatological, neurological, gynecological, or gastrointestinal systems
    • Pregnancy or unwillingness to utilize contraception
    • History of alcohol or drug abuse within 6 months of screening or current alcohol intake >3 drinks/day
  6. Laboratory Exclusions (available values obtained within 8 weeks prior to screening visit are acceptable for all except the pregnancy test)

    • Positive pregnancy test
    • Hemoglobin less than 11.0 g/dL (women) or 13.0 g/dL (men)
    • Platelet count < 120, 000/μL
    • Serum creatinine level > 1.4 mg/dL (women) or 1.6 mg/dL (men)
    • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level greater than 2.5 times the upper limit of normal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467584
Other Study ID Numbers  ICMJE 06-004850
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dean Wingerchuk, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Multiple Sclerosis Society
Investigators  ICMJE
Principal Investigator: Dean M. Wingerchuk, M.D., MSc Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP