Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
What it found
The trial was stopped early because the treatment was not working.
Reason given: Interim analysis indicated treatment unlikely effective;slow recruitment
What was tested
Treatment tested
- Aspirin
Cyclooxygenase inhibitor
Placebo
- Placebo
Results by group
Modified Fatigue Impact Scale Score
Baseline, 8 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| High Dose Aspirin | 48 units on a scale | 13 (Standard Deviation) | 17 |
| Low Dose Aspirin | 50 units on a scale | 15 (Standard Deviation) | 15 |
| Placebo | 49 units on a scale | 13 (Standard Deviation) | 20 |
| High Dose Aspirin | 37 units on a scale | 11 (Standard Deviation) | 17 |
| Low Dose Aspirin | 45 units on a scale | 17 (Standard Deviation) | 15 |
| Placebo | 44 units on a scale | 13 (Standard Deviation) | 20 |
| High Dose Aspirin | -11.4 units on a scale | 13.9 (Standard Deviation) | 17 |
| Low Dose Aspirin | -5.1 units on a scale | 15.7 (Standard Deviation) | 15 |
| Placebo | -5.5 units on a scale | 9.8 (Standard Deviation) | 20 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| High Dose Aspirin | 17 | 0 (0.0%) | |
| Low Dose Aspirin | 15 | 0 (0.0%) | |
| Placebo | 20 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Modified Fatigue Impact Scale Score
Baseline, 8 weeks
Fatigue
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).
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History
Started
Jul 2007
Main results due
Sept 2013
Finished
Sept 2013
Results posted
May 2014