Orpheus Study – Gemlapodect in the Treatment of Adults with Childhood Onset Fluency Disorder (Stuttering)

At the CNS Summit meeting held in Boston this week, the results of the Orpheus study were released in a poster presentation with STARS founder, Gerald A. Maguire MD, as the lead author.  The study, sponsored by Noema Pharma (noemapharma.com) investigated  gemlapodect in the treatment of adults with Childhood Onset Fluency Disorder (Stuttering.) Gemlapodect is an investigational medication that acts as a PDE 10A inhibitor that may modulate the hyperactivity of dopamine signaling in the brain striatal regions postulated to underlie stuttering. The study involved a novel placebo-response randomization design and utilized a newly developed rating scale (the MLGSSS) to assess stuttering severity. When removing subjects who showed initial placebo response, gemlapodect showed a significant treatment effect compared to placebo. Gemlapodect was generally well tolerated with side effects (reported as mild to moderate) of sedation, akathisia (restlessness) and dystonia (muscle stiffness) greater than placebo. Unlike previously studied dopamine blocking medications in stuttering, weight gain was not observed.

Although gemlapodect remains investigational and further research is needed, this work marks a promising step forward in stuttering treatment.