Publications by authors named "M Wieman"
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.
Introduction: Deutetrabenazine is approved by the US Food and Drug Administration to treat tardive dyskinesia (TD) based on 2 pivotal, 12-week, placebo-controlled studies (ARM-TD and AIM-TD) evaluating safety and efficacy in patients with baseline total motor Abnormal Involuntary Movement Scale (AIMS) score ≥6. This analysis estimated the minimal clinically important change (MCIC) in total motor AIMS score in TD patients treated with deutetrabenazine.
Methods: The pooled analysis population included all patients in ARM-TD and AIM-TD who received study drug and had ≥1 postbaseline AIMS assessment.
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.
Objective: The reformulation of oxycodone hydrochloride controlled-release (CR) tablets in August 2010 created a natural experiment at a national scale, providing an opportunity to evaluate patterns of abuse of prescription opioids and other drugs before and after introduction of this abuse-deterrent formulation (ADF).
Design: Observational, cross-sectional study
Setting: Sentinel sample of adults assessed for substance abuse treatment within the NAVIPPRO® surveillance system
Subjects: Two hundred thirty-two thousand and eight hundred seventy-four adults at 437 facilities during January 1, 2008 through December 31, 2011.
Methods: Time-series analysis using logistic regression to estimate quarterly prevalence of past 30-day abuse (adjusted for covariates and prescription volume) and changes in abuse pre-and post-ADF introduction.