Treatment of Multiple Sclerosis With Copaxone and Albuterol

Completed · Not applicable · Has a placebo group

Conditions studied: Autoimmune Diseases, Multiple Sclerosis

In brief

The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.

Key facts

Study ID

NCT00039988

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

2001-11-01

Expected to finish

2007-11-01

Last updated by the study team

2016-09-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Have been diagnosed with RR-MS, within 2 years of diagnosis.
• Are 18-55 years old.
• Have RR-MS with evidence of demyelination on MRI scanning of the brain.
• Have extended disability status scale (EDSS) scores between 0 and 3.5.
• Have not taken Copaxone or oral myelin.
• Have not had immunomodulating therapy for the past 3 months.
• Have not taken immunosuppressants.
• Have not had steroid treatment 1 month before entry.
• Have no evidence of active infection or cancer.

You may not qualify if…

• Patients may not be eligible for this study if they:
• Have a normal brain MRI.
• Are not willing to practice contraception (applies to women who are able to have children).
• Are pregnant or breast-feeding.
• Are currently taking any of the following drugs: beta2-adrenergic agonist or antagonist, diuretics, tricyclic antidepressants, or monoamine oxidase inhibitors.
• Have heart, blood, liver, or kidney problems.
• Have a disease that affects blood clotting or lung function.
• Have abnormalities that relate to the endocrine system.
• Have a history of alcohol or drug abuse within 6 months of enrollment.
• Have been diagnosed with primary progressive MS, in which the disease slowly worsens without periods of recovery.

Where it is running

• Brigham and Women's Hospital/Harvard Medical School — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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