Session Information
Date: Tuesday, June 21, 2016
Session Title: Tics/Stereotypies
Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: This study explored the safety, tolerability and preliminary efficacy of SD-809 (deutetrabenazine) in adolescents with moderate to severe tics associated with Tourette syndrome (TS).
Background: SD-809, an inhibitor of vesicular monoamine transporter type 2 (VMAT2), depletes presynaptic dopamine and therefore has utility in the treatment of various hyperkinetic movement disorders including tics.
Methods: In this open-label study, 12-18 year old patients with TS-related troublesome tics were titrated up to 36 mg/day over 6 weeks to adequately control tics while maintaining tolerability, followed by maintenance at this dose for 2 weeks. An independent blinded rater assessed tic severity using the Yale Global Tic Severity Scale (YGTSS) and tic impact using the TS-Clinical Global Impression (TS-CGI). Other secondary outcome measures included Patient Global Impression of Change (PGIC). Safety was assessed by monitoring adverse events (AEs), vital signs, physical examination, 12-lead ECGs, clinical laboratory tests and safety scales.
Results: 23 enrolled patients received SD-809 and had at least 1 post-baseline YGTSS assessment. Mean (SD) YGTSS Total Tic Score at baseline was 31.6 (7.9) which improved by 11.6 (8.2) at endpoint, representing a 37.6% reduction in tic severity (p<0.0001). At week 8, the mean (SD) TS-CGI score improved by 1.2 (0.81) points (p<0.0001). PGIC results at week 8 indicated that 75% of subjects described themselves as much or very much improved compared to before treatment. Mean dose at endpoint was 32.1 mg/day. One week after withdrawal of SD-809, statistically significant increases were observed in a number of YGTSS component scores. No serious or severe AEs were reported. One subject withdrew from the study for an AE of irritability that was unrelated to study drug.
Conclusions: SD-809 was well tolerated and associated with clinically meaningful improvement in tic severity. Our findings support further development of SD-809 for treatment of TS.
To cite this abstract in AMA style:
J. Jankovic, J. Jimenez-Shahed, C. Budman, B. Coffey, T.K. Murphy, D. Shprecher, D. Stamler. A pilot study of SD-809 (deutetrabenazine) in tics associated with Tourette syndrome [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/a-pilot-study-of-sd-809-deutetrabenazine-in-tics-associated-with-tourette-syndrome/. Accessed May 13, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-pilot-study-of-sd-809-deutetrabenazine-in-tics-associated-with-tourette-syndrome/