Clinical Trial: ReWRAP: Remyelination for Women at Risk for Axonal Loss and Progression

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
Stephanie.hsu@ucsf.edu
415-502-7209