Trimesta is an oral estriol designed for treating relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients, and has been approved throughout Europe and Asia to treat post-menopausal symptoms.
The Phase II trial is a randomized double-blind placebo-controlled study expected to enroll 64 relapsing-remitting or secondary-progressive female MS patients.
In the study, the primary objective is the average change in Paced Auditory Serial Addition Test (PASAT) scores at 12 months between each group, and secondary endpoints include relapse rates, whole brain atrophy determined by MRI and safety.
Principal investigator of the study Rhonda Voskuhl said the aim of this trial is to address the unmet need for MS patients, improving a person’s mental sharpness and ability to continue working.
Currently, another 15-center Phase II randomized double-blind placebo-controlled clinical trial is underway, intended to demonstrate Trimesta’s ability to reduce relapse rates in women with the relapsing-remitting form of MS.