PMID- 17588242
OWN - NLM
STAT- MEDLINE
DCOM- 20080416
LR  - 20151119
IS  - 1531-8257 (Electronic)
IS  - 0885-3185 (Linking)
VI  - 22
IP  - 9
DP  - 2007 Jul 15
TI  - Botulinum toxin type B (Myobloc) in subjects with hemifacial spasm: results from 
      an open-label, dose-escalation safety study.
PG  - 1258-64
AB  - OBJECTIVE: Evaluate the safety of botulinum toxin type B (BoNT-B) in subjects 
      with hemifacial spasm (HFS). METHODS: This open-label, sequential dose-escalation 
      study evaluated BoNT-B in subjects with HFS. Eligible subjects were enrolled and 
      received a single injection of one of four sequential BoNT-B doses (100, 200, 
      400, or 800 U). Following injection, subjects were evaluated in person at Weeks 2 
      and 8 and by phone at Weeks 1, 4, and 10 and every 2 weeks thereafter until 
      benefit was lost. Safety was assessed by adverse events (AEs), vital signs and 
      clinical laboratory evaluation. The severity of HFS was assessed using a patient 
      social impairment visual analog scale (VAS), subject severity of contraction VAS, 
      the HFS physician assessment, and subject HFS frequency and severity assessment. 
      RESULTS: Nineteen predominately Caucasian (92%) and female (67%) subjects (aged 
      36-80 years) with HFS participated in this study. Subjects remained in the study 
      an average of 88 days (range of 41-332 days) after receiving a single dose of 
      BoNT-B. No deaths, serious AEs or AEs leading to trial discontinuation occurred 
      during the study period. Two subjects in the 400 U dose group requested early 
      withdrawal, whereas all other subjects completed the study. A reduction in HFS 
      severity was observed in subjects treated with doses of 200 U or more. 
      Improvements in subject HFS assessments tended to return to baseline values by 8 
      weeks following injection. CONCLUSION: BoNT-B was well-tolerated and reduced HFS 
      severity in subjects who received injections of 200 to 800 U. Additional 
      investigation is necessary to confirm the findings from this open-label study.
CI  - 2007 Movement Disorder Society
FAU - Trosch, Richard M
AU  - Trosch RM
AD  - The Parkinson's Disease and Movement Disorders Center, 26400 W, Southfield, 
      Michigan, USA.
FAU - Adler, Charles H
AU  - Adler CH
FAU - Pappert, Eric J
AU  - Pappert EJ
LA  - eng
PT  - Clinical Trial
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Mov Disord
JT  - Movement disorders : official journal of the Movement Disorder Society
JID - 8610688
RN  - 0 (Anti-Dyskinesia Agents)
RN  - 0Y70779M1F (rimabotulinumtoxinB)
RN  - EC 3.4.24.69 (Botulinum Toxins)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Dyskinesia Agents/*therapeutic use
MH  - Botulinum Toxins/*therapeutic use
MH  - Botulinum Toxins, Type A
MH  - Dose-Response Relationship, Drug
MH  - *Drug Evaluation
MH  - Female
MH  - Hemifacial Spasm/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2007/06/26 09:00
MHDA- 2008/04/17 09:00
CRDT- 2007/06/26 09:00
PHST- 2007/06/26 09:00 [pubmed]
PHST- 2008/04/17 09:00 [medline]
PHST- 2007/06/26 09:00 [entrez]
AID - 10.1002/mds.21435 [doi]
PST - ppublish
SO  - Mov Disord. 2007 Jul 15;22(9):1258-64. doi: 10.1002/mds.21435.