Treatment of Multiple Sclerosis With Copaxone and Albuterol
NCT00039988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2016-09-22
Summary
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.
Conditions
Interventions
- DRUG
-
Glatiramer acetate
20 mg administered subcutaneously daily
- DRUG
-
Albuterol
2 mg or 4 mg oral capsules taken daily
- DRUG
-
Albuterol placebo
Oral placebo capsules will be taken daily
Sponsors & Collaborators
-
Autoimmunity Centers of Excellence
collaborator OTHER -
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Samia Khoury · Brigham and Women's Hospital/Harvard Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-11-30
- Primary Completion
- 2006-03-31
- Completion
- 2007-11-30
Countries
- United States
Study Locations
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