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Details (415) 502-7209 stephanie.hsu@ucsf.edu Type of MS: Relapsing-Remitting MSTreatment mode of action: To repair myelinNumber of Subjects: 60Medication: BazedoxifeneLocation: Arizona, California, Colorado, Nevada, New Mexico, Oregon, Texas, Utah, Washington Institutions: Contact Information: (415) 502-7209 stephanie.hsu@ucsf.edu 415-502-7209 stephanie.hsu@ucsf.edu Funding: Sherak Foundation, National MS Society Description: Dr. Riley Bove and her colleagues at the UCSF Multiple Sclerosis center are conducting a clinical trial to assess the efficacy of bazedoxifene (BZA) in promoting the repair of myelin (remyelination), an important insulating layer for neurons in the central nervous system affected by MS, in women ages 45 to 65 (or 40+ if postmenopausal). BZA is a selective estrogen receptor modulator (SERM) – a molecule that acts as a promoter where estrogen is thought to have beneficial effects (e.g. bones, cardiovascular system and the central nervous system) and as an inhibitor to estrogen receptor over-activation in breast and endometrial tissue. It is approved in the EU and Japan for treatment of postmenopausal osteoporosis, but this will be the first time it is studied for the purpose of promoting remyelination. Participants in this study will be asked to visit our UCSF Mission Bay campus 4 times: once for screening and 3 additional times over the course of the 6-month trial period. Individuals who fit the inclusion criteria will be randomly assigned to receive 6 months of BZA, or 3 months of inactive placebo followed by 3 months of BZA. The efficacy of BZA in promoting myelin repair will be assessed through electrophysiologic techniques (visual evoked potentials), MRI, visual testing and motor-task evaluation. Main inclusion criteria: Women aged 45 – 65 (or 40+ postmenopausal) with a diagnosis of relapsing-remitting multiple sclerosis Stable immunomodulatory therapy Expanded disability status scale (EDSS) between 0.0 and 6.0 (inclusive) If you would like to participate, please contact the study coordinator: Stephanie Hsu 415-502-7209 stephanie.hsu@ucsf.edu 415-502-7209 stephanie.hsu@ucsf.edu Funding: Sherak Foundation, National MS Society Description: Dr. Riley Bove and her colleagues at the UCSF Multiple Sclerosis center are conducting a clinical trial to assess the efficacy of bazedoxifene (BZA) in promoting the repair of myelin (remyelination), an important insulating layer for neurons in the central nervous system affected by MS, in women ages 45 to 65 (or 40+ if postmenopausal). BZA is a selective estrogen receptor modulator (SERM) – a molecule that acts as a promoter where estrogen is thought to have beneficial effects (e.g. bones, cardiovascular system and the central nervous system) and as an inhibitor to estrogen receptor over-activation in breast and endometrial tissue. It is approved in the EU and Japan for treatment of postmenopausal osteoporosis, but this will be the first time it is studied for the purpose of promoting remyelination. Participants in this study will be asked to visit our UCSF Mission Bay campus 4 times: once for screening and 3 additional times over the course of the 6-month trial period. Individuals who fit the inclusion criteria will be randomly assigned to receive 6 months of BZA, or 3 months of inactive placebo followed by 3 months of BZA. The efficacy of BZA in promoting myelin repair will be assessed through electrophysiologic techniques (visual evoked potentials), MRI, visual testing and motor-task evaluation. Main inclusion criteria: Women aged 45 – 65 (or 40+ postmenopausal) with a diagnosis of relapsing-remitting multiple sclerosis Stable immunomodulatory therapy Expanded disability status scale (EDSS) between 0.0 and 6.0 (inclusive) If you would like to participate, please contact the study coordinator: Stephanie Hsu 415-502-7209 stephanie.hsu@ucsf.edu
CT ReWRAP Remyelination for Women