Treatment of RRMS With Copaxone® and Albuterol
Location: Brigham and Women’s Hospital/Harvard Medical School, Boston, MA
Purpose: To determine the effects of Copaxone alone compared to Copaxone plus albuterol in persons with MS.
Eligibility:
• Women and men 18 to 55 years of age
• Have been diagnosed with RRMS within past 2 years
• Have RRMS with evidence of demyelination on MRI scanning of the brain
• Have EDSS scores between 0 and 3.5
• Have not taken Copaxone or oral myelin
• Have not had immuno-modulating therapy for past 3 months
• Have not taken immunosuppressants
• Have not had steroid treatment 1 month before entry into study
• Have no evidence of active infection or cancer.
There are also several exclusion criteria.
Procedure: During pre-treatment phase, undergo neurological exams, including the EDSS, ambulation index (AI), disease steps (DS) scale MS functional composite score, PASAT, 9HPT, and the Timed 25-Foot Walk. A 12-lead EKG and chest X-ray are performed. Serum chemistry is assessed as well as electrolyte and thyroid stimulate 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, participants are assigned randomly to one of two study groups. Those in the “Arm 1†group will receive Copaxone plus placebo and those in the “Arm 2†group will receive Copaxone plus albuterol. At the treatment visits, blood will be collected and neurological exams and a brain MRI will be performed. A pregnancy test will be given to women of reproductive potential. Neurological exams will be performed every 6 months. MRIs will be performed at Baseline, year 1 and year 2. At the end of the study, participants will have a complete physical exam, a neurological exam, and a brain MRI.
Benefit: May lead to a new combination therapy for RRMS.
For Information: Contact Sandra Cook either by telephone at 617617-713-2006, or via e-mail:
scook@partners.org