Primary Outcome Measures:
- Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC)
- glatiramer acetate-specific cytokine secretion at Months 3, 6 and 12, compared to baseline measurement of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines
Secondary Outcome Measures:
- Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate
- change in percentage of IL-12-producing monocytes by intracytoplasmic staining
- time to first exacerbation
- number and severity of exacerbations
- MRI evidence at baseline and Months 12 and 24 of MS progression, as measured by T2 lesion volume, number of enhancing lesions on T1 weighted images, and measurements of atrophy (brain parenchymal fraction, atrophy index)
- Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores
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.