PMID- 27917309
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200603
IS  - 2160-8288 (Print)
IS  - 2160-8288 (Electronic)
IS  - 2160-8288 (Linking)
VI  - 6
DP  - 2016
TI  - Deutetrabenazine in Tics Associated with Tourette Syndrome.
PG  - 422
LID - 422
AB  - BACKGROUND: Deutetrabenazine, an inhibitor of vesicular monoamine transporter 
      type 2 (VMAT2) depletes presynaptic dopamine and is useful in the treatment of 
      hyperkinetic movement disorders. This study explored the safety, tolerability, 
      and preliminary efficacy of deutetrabenazine in adolescents with 
      moderate-to-severe tics associated with Tourette syndrome (TS). METHODS: In this 
      open-label study of 12-18-year-old patients with TS-related tics, 
      deutetrabenazine was titrated up to 36 mg/day over 6 weeks to adequately suppress 
      tics without bothersome adverse effects (AEs), followed by maintenance at optimal 
      dose for 2 weeks. An independent blinded rater assessed tic severity using the 
      Yale Global Tic Severity Scale (YGTSS), which was the primary outcome measure. 
      Secondary outcome measures included the TS Clinical Global Impression (TS-CGI) 
      and TS Patient Global Impression of Change (TS-PGIC). RESULTS: Twenty-three 
      enrolled patients received deutetrabenazine and had at least 1 post-baseline 
      YGTSS assessment. The mean (SD [standard deviation]) baseline YGTSS Total Tic 
      Severity Score (TTS) was 31.6 (7.9) and had decreased by 11.6 (8.2) points at 
      week 8, a 37.6% reduction in tic severity (p<0.0001). The TS-CGI score improved 
      by 1.2 (0.81) points (p<0.0001) and the TS-PGIC results at week 8 indicated that 
      76% of patients were much improved or very much improved compared with baseline. 
      The mean (SD) daily deutetrabenazine dose at week 8 was 32.1 (6.6) mg (range 
      18-36 mg). One week after withdrawal of deutetrabenazine, the TTS scores 
      increased by 5.6 (8.4) points, providing confirmation of the drug effect. No 
      serious or severe adverse events were reported. DISCUSSION: The results of this 
      open-label 8-week study suggest that deutetrabenazine is safe and associated with 
      improvement in tic severity in adolescents with TS and troublesome tics.
FAU - Jankovic, Joseph
AU  - Jankovic J
AD  - Baylor College of Medicine, Houston, TX, USA.
FAU - Jimenez-Shahed, Joohi
AU  - Jimenez-Shahed J
AD  - Baylor College of Medicine, Houston, TX, USA.
FAU - Budman, Cathy
AU  - Budman C
AD  - North Shore University Hospital/Northwell Health, Manhasset, NY, USA.
FAU - Coffey, Barbara
AU  - Coffey B
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Murphy, Tanya
AU  - Murphy T
AD  - University of South Florida, Tampa, FL, USA.
FAU - Shprecher, David
AU  - Shprecher D
AD  - Banner Sun Health Research Institute, Sun City, AZ, USA; University of Utah, Salt 
      Lake City, Utah, USA.
FAU - Stamler, David
AU  - Stamler D
AD  - Auspex, wholly owned subsidiary of Teva Pharmaceutical Industries, La Jolla, CA, 
      USA.
LA  - eng
PT  - Journal Article
DEP - 20161107
PL  - England
TA  - Tremor Other Hyperkinet Mov (N Y)
JT  - Tremor and other hyperkinetic movements (New York, N.Y.)
JID - 101569493
PMC - PMC5133390
OTO - NOTNLM
OT  - SD-809
OT  - Tics
OT  - Tourette syndrome
OT  - VMAT2
OT  - deutetrabenazine
COIS- Funding: This report describes a study funded by Auspex, a wholly owned 
      subsidiary of Teva Pharmaceutical Industries, Petah Tikva, Israel. Conflict of 
      Interest: The authors report no conflict of interest. Ethics Statement: The study 
      was conducted in accordance with the principles of Good Clinical Practice, and 
      with the FDA guidelines on safety monitoring by Institutional Review Boards for 
      Human Research. Written informed consent by parent/guardian and assent of the 
      adolescent was obtained before study participation. This study was performed in 
      accordance with the ethical standards detailed in the Declaration of Helsinki. 
      The authors' institutional ethics committee has approved this study and all 
      patients have provided written informed consent.
EDAT- 2016/12/06 06:00
MHDA- 2016/12/06 06:01
PMCR- 2016/11/07
CRDT- 2016/12/06 06:00
PHST- 2016/08/15 00:00 [received]
PHST- 2016/10/17 00:00 [accepted]
PHST- 2016/12/06 06:00 [entrez]
PHST- 2016/12/06 06:00 [pubmed]
PHST- 2016/12/06 06:01 [medline]
PHST- 2016/11/07 00:00 [pmc-release]
AID - 10.7916/D8M32W3H [doi]
PST - epublish
SO  - Tremor Other Hyperkinet Mov (N Y). 2016 Nov 7;6:422. doi: 10.7916/D8M32W3H. 
      eCollection 2016.