Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

NCT00467584 | Terminated Phase 3 Results

• 1 other identifier: 06-004850
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).

Conditions

Multiple Sclerosis; Fatigue

Outcome Measures

Primary Outcomes (1)

• Modified Fatigue Impact Scale Score

  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.

  Baseline, 8 weeks

Study Arms (3)

High Dose Aspirin

ACTIVE COMPARATOR

High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks

Drug: High Dose Aspirin (1300 mg/day)

Low Dose Aspirin

ACTIVE COMPARATOR

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

Drug: Low Dose Aspirin (162 mg/day)

Placebo

PLACEBO COMPARATOR

Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks

Drug: Placebo

Interventions

High Dose Aspirin (1300 mg/day) DRUG

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

Also known as: acetylsalicylic acid, ASA, Aspirin

High Dose Aspirin

Low Dose Aspirin (162 mg/day) DRUG

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

Also known as: acetylsalicylic acid, ASA, Aspirin

Low Dose Aspirin

Placebo DRUG

Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination leading to smaller number of subjects analyzed.

Results Point of Contact

• Title: Dr. Dean M. Wingerchuk
• Organization: Mayo Clinic

wingerchuk.dean@mayo.edu

480-301-6328

Study Officials

• Dean M. Wingerchuk, M.D., MSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 30, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 20, 2014
• Results First Posted: May 16, 2014

Record last verified: 2014-05

Locations

US (1)