PMID- 23779062
OWN - NLM
STAT- MEDLINE
DCOM- 20140709
LR  - 20220321
IS  - 1435-1463 (Electronic)
IS  - 0300-9564 (Print)
IS  - 0300-9564 (Linking)
VI  - 120
IP  - 12
DP  - 2013 Dec
TI  - A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in 
      cervical dystonia.
PG  - 1699-707
LID - 10.1007/s00702-013-1048-3 [doi]
AB  - IncobotulinumtoxinA (Xeomin((R)), NT 201), a preparation without accessory 
      (complexing) proteins, has shown comparable efficacy and safety to 
      onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the 
      efficacy and safety of repeated incobotulinumtoxinA injections in subjects with 
      CD. Following a </=20-week placebo-controlled, randomized, double-blind, 
      single-dose main period, subjects could enter a </=68-week prospective, randomized, 
      double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period 
      with 240 U or 120 U of incobotulinumtoxinA (</=5 injections). Outcome measures 
      included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and 
      adverse events (AEs). Of 219 subjects completing the main period, 214 were 
      randomized in the extension period to receive incobotulinumtoxinA 240 U (n = 111) 
      or 120 U (n = 103); 169 subjects completed the extension period, with 90 
      receiving five injection sessions. Both doses of incobotulinumtoxinA provided 
      statistically significant and clinically relevant improvements in mean 
      TWSTRS-Total, -Severity, -Disability, and -Pain scores, from each injection 
      session to respective 4-week follow-up visits. The most frequently reported AE 
      was dysphagia (240 U: 23.4 %; 120 U: 12.6 %), which did not result in any study 
      withdrawals. There was no impact of injection interval on the incidence of AEs 
      (post hoc analysis). A major limitation of this study was the fixed dose design 
      requested by regulatory authorities, which does not reflect clinical practice. 
      However, repeated incobotulinumtoxinA injections (240 or 120 U; flexible 
      intervals) provided sustained efficacy and were well tolerated, with no 
      unexpected safety risks following repeated injections. The incidence of AEs was 
      similar in subjects requiring repeated injections at shorter intervals 
      (</=12 weeks) compared with those treated using longer intervals (>12 weeks).
FAU - Evidente, Virgilio Gerald H
AU  - Evidente VG
AD  - Movement Disorders Center of Arizona, 9590 E. Ironwood Square Drive, #225, 
      Scottsdale, AZ, 85258, USA, vevidente@movementdisorders.us.
FAU - Fernandez, Hubert H
AU  - Fernandez HH
FAU - LeDoux, Mark S
AU  - LeDoux MS
FAU - Brashear, Allison
AU  - Brashear A
FAU - Grafe, Susanne
AU  - Grafe S
FAU - Hanschmann, Angelika
AU  - Hanschmann A
FAU - Comella, Cynthia L
AU  - Comella CL
LA  - eng
GR  - R01 NS058949/NS/NINDS NIH HHS/United States
GR  - R01-NS058949/NS/NINDS NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20130619
PL  - Austria
TA  - J Neural Transm (Vienna)
JT  - Journal of neural transmission (Vienna, Austria : 1996)
JID - 9702341
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (incobotulinumtoxinA)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/*therapeutic use
MH  - Severity of Illness Index
MH  - Torticollis/*drug therapy
MH  - Treatment Outcome
PMC - PMC3834167
EDAT- 2013/06/20 06:00
MHDA- 2014/07/10 06:00
PMCR- 2013/06/19
CRDT- 2013/06/20 06:00
PHST- 2013/01/09 00:00 [received]
PHST- 2013/05/23 00:00 [accepted]
PHST- 2013/06/20 06:00 [entrez]
PHST- 2013/06/20 06:00 [pubmed]
PHST- 2014/07/10 06:00 [medline]
PHST- 2013/06/19 00:00 [pmc-release]
AID - 1048 [pii]
AID - 10.1007/s00702-013-1048-3 [doi]
PST - ppublish
SO  - J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 
      10.1007/s00702-013-1048-3. Epub 2013 Jun 19.