PMID- 20021666
OWN - NLM
STAT- MEDLINE
DCOM- 20100224
LR  - 20220408
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 9
DP  - 2009 Dec 18
TI  - Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label 
      continuation study. Huntington Study Group/TETRA-HD Investigators.
PG  - 62
LID - 10.1186/1471-2377-9-62 [doi]
AB  - BACKGROUND: Tetrabenazine (TBZ) selectively depletes central monoamines by 
      reversibly binding to the type-2 vesicular monoamine transporter. A previous 
      double blind study in Huntington disease (HD) demonstrated that TBZ effectively 
      suppressed chorea, with a favorable short-term safety profile (Neurology 
      2006;66:366-372). The objective of this study was to assess the long-term safety 
      and effectiveness of TBZ for chorea in HD. METHODS: Subjects who completed the 
      13-week, double blind protocol were invited to participate in this open label 
      extension study for up to 80 weeks. Subjects were titrated to the best individual 
      dose or a maximum of 200 mg/day. Chorea was assessed using the Total Maximal 
      Chorea (TMC) score from the Unified Huntington Disease Rating Scale. RESULTS: Of 
      the 75 participants, 45 subjects completed 80 weeks. Three participants 
      terminated due to adverse events (AEs) including depression, delusions with 
      associated previous suicidal behavior, and vocal tics. One subject died due to 
      breast cancer. The other 26 subjects chose not to continue on with each ensuing 
      extension for various reasons. When mild and unrelated AEs were excluded, the 
      most commonly reported AEs (number of subjects) were sedation/somnolence (18), 
      depressed mood (17), anxiety (13), insomnia (10), and akathisia (9). Parkinsonism 
      and dysarthria [corrected] scores were significantly increased at week 80 
      compared to baseline. At week 80, chorea had significantly improved from baseline 
      with a mean reduction in the TMC score of 4.6 (SD 5.5) units. The mean dosage at 
      week 80 was 63.4 mg (range 12.5-175 mg). CONCLUSIONS: TBZ effectively suppresses 
      HD-related chorea for up to 80 weeks. Patients treated chronically with TBZ 
      should be monitored for parkinsonism, dysphagia and other side effects including 
      sleep disturbance, depression, anxiety, and akathisia. TRIAL REGISTRATION: 
      Clinicaltrials.gov registration number (initial study): NCT00219804.
FAU - Frank, Samuel
AU  - Frank S
AD  - samuel.frank@bmc.org
LA  - eng
SI  - ClinicalTrials.gov/NCT00219804
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20091218
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Adrenergic Uptake Inhibitors)
RN  - Z9O08YRN8O (Tetrabenazine)
SB  - IM
EIN - BMC Neurol. 2011;11:18
MH  - Adrenergic Uptake Inhibitors/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Drug Evaluation/methods
MH  - Follow-Up Studies
MH  - Humans
MH  - Huntington Disease/*drug therapy
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Tetrabenazine/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC2804668
EDAT- 2009/12/22 06:00
MHDA- 2010/02/25 06:00
PMCR- 2009/12/18
CRDT- 2009/12/22 06:00
PHST- 2009/03/20 00:00 [received]
PHST- 2009/12/18 00:00 [accepted]
PHST- 2009/12/22 06:00 [entrez]
PHST- 2009/12/22 06:00 [pubmed]
PHST- 2010/02/25 06:00 [medline]
PHST- 2009/12/18 00:00 [pmc-release]
AID - 1471-2377-9-62 [pii]
AID - 10.1186/1471-2377-9-62 [doi]
PST - epublish
SO  - BMC Neurol. 2009 Dec 18;9:62. doi: 10.1186/1471-2377-9-62.