A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)

Summary

The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test. The absolute change from baseline in meters/second observed in each treatment group at 6 Month was compared to the placebo group. Due to the Covid pandemic \>50% of data at endpoint was missing, which may have affected the ability of the study to deliver the expected results. Additionally, although the planned duration of treatment was 6 months, it was extended up to 9 months for some participants as a result of the pandemic.

Timeline

Start

2017-02-07

Primary completion

2020-04-26

Completion

2020-04-26

Drugs

Indications