Phase 2 Trial for Sciatica
A Phase 2 trial of our Clonidine Micropellet investigational therapy (STX-015) was conducted to study the pharmacokinetics, safety, and preliminary efficacy of escalating doses in adults with lumbosacral radiculopathy. The study comprised 54 subjects in 3 different dose cohorts.
Status: Study complete
Findings: There was a statistically significant reduction in leg pain from baseline within 2 days that was durable for at least one year (maximum time point studied) in all cohorts with similar improvement in each group. All cohorts showed significant improvement in the Roland-Morris Disability Scale (RMS-L) at all timepoints.
The Sollis Clonidine Micropellet therapy is an investigational treatment for sciatica and has not been approved for use by the FDA.