Adeona Pharmaceuticals, Inc. (AEN) announced the initiation of the Phase II clinical trial of Trimesta (oral estriol) for treating cognitive dysfunction in multiple sclerosis, or MS.
The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates, whole brain atrophy determined by MRI and safety.
Dr. Voskuhl, Principal Investigator, said, "We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability. The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."
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