PMID- 31342515
OWN - NLM
STAT- MEDLINE
DCOM- 20200713
LR  - 20200713
IS  - 1526-4610 (Electronic)
IS  - 0017-8748 (Print)
IS  - 0017-8748 (Linking)
VI  - 59
IP  - 8
DP  - 2019 Sep
TI  - Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion 
      for the Treatment of Classical Trigeminal Neuralgia.
PG  - 1229-1239
LID - 10.1111/head.13608 [doi]
AB  - BACKGROUND: The sphenopalatine ganglion (SPG) has previously been targeted in 
      trigeminal neuralgia (TN), but its role in this condition has not been 
      established. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxinA 
      (BTA) toward the SPG using the MultiGuide((R)) in 10 patients with refractory 
      classical TN, and collect preliminary efficacy data. METHODS: Twenty-five 
      international units (IU) of BTA were injected toward the SPG in a prospective, 
      open-label study in 10 patients with refractory classical TN. All patients were 
      recruited and treated on an out-patient basis at St. Olav's University Hospital 
      in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy 
      outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. 
      A treatment responder was predefined as at least 50% reduction in the median 
      number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes 
      were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 
      to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. 
      Percentage of the day with concomitant persistent pain was registered at baseline 
      and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of 
      change (PGIC) was ascertained at month 3. RESULTS: For the primary endpoint, we 
      analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 
      patients (1 patient violated protocol). We registered 13 AEs, none of which were 
      serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 
      after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively 
      (P = .401). Four patients were treatment responders. The median intensity of 
      attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 
      (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline 
      was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median 
      percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, 
      maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 
      (P = .023). CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide((R)) 
      in patients with TN appears to be safe and well tolerated. This study was 
      negative for the main efficacy endpoint (reduction in the number of attacks from 
      baseline to weeks 5-8). Further studies examining the role of the SPG in TN are 
      necessary.
CI  - (c) 2019 Authors. Headache: The Journal of Head and Face Pain published by Wiley 
      Periodicals, Inc. on behalf of American Headache Society.
FAU - Crespi, Joan
AU  - Crespi J
AD  - Department of Neurology, St. Olav's University Hospital, Trondheim, Norway.
AD  - Department of Neuromedicine and Movement Science, NTNU (University of Science and 
      Technology), Trondheim, Norway.
AD  - Norwegian Advisory Unit on Headaches, Trondheim, Norway.
FAU - Bratbak, Daniel
AU  - Bratbak D
AD  - Department of Neuromedicine and Movement Science, NTNU (University of Science and 
      Technology), Trondheim, Norway.
AD  - Department of Neurosurgery, St. Olav's University Hospital, Trondheim, Norway.
FAU - Dodick, David W
AU  - Dodick DW
AD  - Department of Neuromedicine and Movement Science, NTNU (University of Science and 
      Technology), Trondheim, Norway.
AD  - Mayo Clinic, Scottsdale, Arizona, USA.
FAU - Matharu, Manjit
AU  - Matharu M
AD  - UCL Queen Square Institute of Neurology, National Hospital for Neurology and 
      Neurosurgery, London, UK.
FAU - Jamtoy, Kent Are
AU  - Jamtoy KA
AD  - Department of Neuromedicine and Movement Science, NTNU (University of Science and 
      Technology), Trondheim, Norway.
AD  - Department of Maxillofacial Surgery, St. Olav's University Hospital, Trondheim, 
      Norway.
FAU - Tronvik, Erling
AU  - Tronvik E
AD  - Department of Neurology, St. Olav's University Hospital, Trondheim, Norway.
AD  - Department of Neuromedicine and Movement Science, NTNU (University of Science and 
      Technology), Trondheim, Norway.
AD  - Norwegian Advisory Unit on Headaches, Trondheim, Norway.
LA  - eng
GR  - 46056923/NTNU (Norwegian University of Science and Technology) and "The Liaison 
      Committee for Education, Research and Innovation in Central Norway" 
      (Samarbeidsorganet)/International
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190725
PL  - United States
TA  - Headache
JT  - Headache
JID - 2985091R
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Injections/*instrumentation/*methods
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/*administration & dosage/adverse effects
MH  - Pilot Projects
MH  - Pterygopalatine Fossa
MH  - Trigeminal Neuralgia/*drug therapy
PMC - PMC6771650
OTO - NOTNLM
OT  - botulinum toxin
OT  - pterygopalatine ganglion
OT  - sensitization
OT  - sphenopalatine ganglion
OT  - trigeminal neuralgia
EDAT- 2019/07/26 06:00
MHDA- 2020/07/14 06:00
PMCR- 2019/10/01
CRDT- 2019/07/26 06:00
PHST- 2019/04/15 00:00 [accepted]
PHST- 2019/07/26 06:00 [pubmed]
PHST- 2020/07/14 06:00 [medline]
PHST- 2019/07/26 06:00 [entrez]
PHST- 2019/10/01 00:00 [pmc-release]
AID - HEAD13608 [pii]
AID - 10.1111/head.13608 [doi]
PST - ppublish
SO  - Headache. 2019 Sep;59(8):1229-1239. doi: 10.1111/head.13608. Epub 2019 Jul 25.