Publications by authors named "D Stamler"
Introduction: Deutetrabenazine is a vesicular monoamine transporter 2 inhibitor used to treat tardive dyskinesia (TD) and chorea associated with Huntington disease (HD). To enhance detection of safety signals across individual trials, integrated safety analyses of deutetrabenazine in TD and HD chorea were conducted.
Methods: For TD, safety data were integrated from two 12-week pivotal studies (ARM-TD and AIM-TD) and through week 15 of the open-label extension (OLE) study (RIM-TD).
Background: Tourette syndrome (TS) is a neurodevelopmental disorder characterized by motor and phonic tics.
Objective: To assess the safety and efficacy of deutetrabenazine (Teva Neuroscience, Inc, Parsippany, NJ), a vesicular monoamine transporter 2 inhibitor, in children and adolescents with TS.
Methods: Alternatives for Reducing Tics in TS (ARTISTS) open-label extension (OLE) (NCT03567291) was a 54-week, global, phase 3, open-label extension study of deutetrabenazine (6-48 mg daily) conducted May 28, 2018 to April 3, 2020 with a 2-week randomized withdrawal period.
Article Synopsis
- Tourette syndrome is a neurodevelopmental disorder that leads to the development of motor and phonic tics, and this study focuses on testing deutetrabenazine, a drug previously approved for other conditions, to see if it can help manage these tics.
- The ARTISTS 2 study recruited children and adolescents aged 6 to 16 with Tourette syndrome, with participants randomly assigned to receive either low-dose, high-dose deutetrabenazine, or a placebo over an 8-week period.
- The main measure of effectiveness was the change in tic severity, assessed using the Yale Global Tic Severity Scale, while safety was evaluated through monitoring side effects and other health metrics.
Importance: Tourette syndrome is a neurodevelopmental disorder characterized by childhood onset of motor and phonic tics; treatments for tics are associated with safety concerns. Deutetrabenazine is a selective vesicular monoamine transporter 2 inhibitor approved for the treatment of chorea associated with Huntington disease and tardive dyskinesia in adults.
Objective: To examine whether deutetrabenazine is effective and safe for the treatment of Tourette syndrome in children and adolescents.