PMID- 30274305
OWN - NLM
STAT- MEDLINE
DCOM- 20190909
LR  - 20190909
IS  - 2072-6651 (Electronic)
IS  - 2072-6651 (Linking)
VI  - 10
IP  - 10
DP  - 2018 Sep 29
TI  - Botulinum Toxin in Restless Legs Syndrome-A Randomized Double-Blind 
      Placebo-Controlled Crossover Study.
LID - 10.3390/toxins10100401 [doi]
LID - 401
AB  - BACKGROUND: Restless Legs Syndrome (RLS) is a common movement disorder with an 
      estimated prevalence of up to 12%. Previous small studies with onabotulinumtoxin 
      A (OnaA) for RLS have shown inconsistent results. METHODS: Twenty-four patients 
      with an International RLS score (IRLS) of >11 (moderate-severe) were enrolled in 
      this blinded, placebo-controlled crossover study. Twenty-one patients completed 
      the evaluations at 4, 6, and 8 weeks after each injection. One-hundred units of 
      Incobotulinumtoxin A (IncoA) or normal saline were injected into tibialis 
      anterior, gastrocnemius, and biceps femoris muscles each side. RESULTS: 
      Improvement from a severe (IRLS >21) to a mild/moderate (IRLS </=20) score was 
      significant at four weeks (p = 0.0036) and six weeks (p = 0.0325) following IncoA 
      administration compared to placebo. Additionally, there was significant 
      improvement in pain score at six weeks as measured by Visual Analogue Scale (p = 
      0.04) and the Johns Hopkins Quality of Life Questionnaire (p = 0.01) in the IncoA 
      group. Definite or marked improvement on Patient Global Impression of Change was 
      seen in 7 out of 21 patients in the IncoA group vs. 1 out of 21 patients in the 
      placebo group at 4 weeks (p = 0.012). CONCLUSION: IncoA injection lead to a 
      reduction in severity of RLS symptoms, pain score, and quality of life, without 
      any adverse effects.
FAU - Mittal, Shivam Om
AU  - Mittal SO
AUID- ORCID: 0000-0003-2138-1108
AD  - Department of Neurology, Yale University School of Medicine, New Haven, CT 06510, 
      USA. neurology.mittal@gmail.com.
AD  - Department of Neurology, Columbia Asia Hospitals, Sarjapur Rd, Bangalore 560102, 
      India. neurology.mittal@gmail.com.
AD  - Department of Neurology, Mayo Clinic, Rochester, MN 55905, USA. 
      neurology.mittal@gmail.com.
FAU - Machado, Duarte
AU  - Machado D
AD  - Department of Neurology, Yale University School of Medicine, New Haven, CT 06510, 
      USA. duarte.machado@hhchealth.org.
AD  - Department of Neurology, Hartford Healthcare Ayer Neuroscience Institute, 
      Hartford, CT 06066, USA. duarte.machado@hhchealth.org.
FAU - Richardson, Diana
AU  - Richardson D
AD  - Department of Neurology, Yale University School of Medicine, New Haven, CT 06510, 
      USA. diana.richardson@va.gov.
FAU - Dubey, Divyanshu
AU  - Dubey D
AD  - Department of Neurology, Mayo Clinic, Rochester, MN 55905, USA. 
      dubey.divyanshu@mayo.edu.
FAU - Jabbari, Bahman
AU  - Jabbari B
AD  - Department of Neurology, Yale University School of Medicine, New Haven, CT 06510, 
      USA. bahman.jabbari@yale.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT01931878
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180929
PL  - Switzerland
TA  - Toxins (Basel)
JT  - Toxins
JID - 101530765
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  - Aged, 80 and over
MH  - Botulinum Toxins, Type A/*therapeutic use
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/*therapeutic use
MH  - Restless Legs Syndrome/*drug therapy
MH  - Severity of Illness Index
PMC - PMC6215171
OTO - NOTNLM
OT  - botulinum toxin
OT  - clinical trial
OT  - incobotulinumtoxin A
OT  - movement disorder
OT  - restless legs syndrome
OT  - sleep
COIS- There is no conflict of interest for any of the authors.
EDAT- 2018/10/03 06:00
MHDA- 2019/09/10 06:00
PMCR- 2018/10/01
CRDT- 2018/10/03 06:00
PHST- 2018/09/06 00:00 [received]
PHST- 2018/09/27 00:00 [revised]
PHST- 2018/09/27 00:00 [accepted]
PHST- 2018/10/03 06:00 [entrez]
PHST- 2018/10/03 06:00 [pubmed]
PHST- 2019/09/10 06:00 [medline]
PHST- 2018/10/01 00:00 [pmc-release]
AID - toxins10100401 [pii]
AID - toxins-10-00401 [pii]
AID - 10.3390/toxins10100401 [doi]
PST - epublish
SO  - Toxins (Basel). 2018 Sep 29;10(10):401. doi: 10.3390/toxins10100401.