Treatment of Multiple Sclerosis With Copaxone and Albuterol
Condition: Autoimmune Diseases; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Autoimmune Diseases; Sclerosis
Study type: Interventional

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.
    

Detailed description: 
      MS is a chronic inflammatory disease of the central nervous system characterized by focal T
      cell and macrophage infiltrates that lead to demyelination and loss of neurologic function.
      Four therapies are currently approved for the treatment of MS. Three of these are approved
      for the treatment of patients with the relapsing-remitting (RR) form of MS, in which patients
      have clinical exacerbations followed by partial or complete recovery of function. These
      treatments are only modestly effective and are associated with significant toxicity, often
      causing patients to delay therapy for significant lengths of time. Thus, there is a need to
      find therapies with low toxicities that can be administered early during the disease course
      with the potential for arresting the disease.

      During the pre-treatment phase, patients undergo neurological exams, including the extended
      disability status scale (EDSS), Ambulation Index (AI), disease steps (DS) scale MS functional
      composite score, PASAT, 9 hole peg test, and the 25 foot walking time. A 12-lead
      electrocardiogram (EKG) and chest x-ray are performed. Serum chemistry is assessed as well as
      electrolyte and thyroid stimulating hormone (TSH) levels. A brain MRI (with and without
      gadolinium), urinalysis, and urine pregnancy test (for women of reproductive potential) are
      performed. Blood is collected for mechanistic studies. In the treatment phase, patients are
      assigned randomly to 1 of 2 study arms:

      Arm 1: Copaxone plus placebo. Arm 2: Copaxone plus albuterol. At the treatment visits, blood
      is collected and neurological exams and a brain MRI are performed. A pregnancy test is
      administered to women of reproductive potential. Neurological exams are performed every 6
      months. MRIs are performed at baseline, Year 1, and Year 2. At the end of the study, patients
      have a complete physical exam, a neurological exam, and a brain MRI.
    

Intervention name(s): Glatiramer acetate; Albuterol; Albuterol placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg administered subcutaneously daily; 2 mg or 4 mg oral capsules taken daily; Oral placebo capsules will be taken daily
Intervention MeSH terms: Glatiramer Acetate; Albuterol; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Treatment Outcome; Multiple Sclerosis; Albuterol; Copolymer 1