PMID- 26232105
OWN - NLM
STAT- MEDLINE
DCOM- 20170314
LR  - 20240325
IS  - 1468-2982 (Electronic)
IS  - 0333-1024 (Print)
IS  - 0333-1024 (Linking)
VI  - 36
IP  - 6
DP  - 2016 May
TI  - Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment 
      of intractable chronic cluster headache.
PG  - 503-9
LID - 10.1177/0333102415597891 [doi]
AB  - OBJECTIVE: The main object of this pilot study was to investigate the safety of 
      administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) 
      in intractable chronic cluster headache. Efficacy data were also collected to 
      provide indication on whether future placebo-controlled studies should be 
      performed. METHOD: In a prospective, open-label, uncontrolled study, we performed 
      a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 
      patients with intractable chronic cluster headache with a follow-up of 24 weeks. 
      The primary outcome was adverse events (AEs) and the main efficacy outcome was 
      attack frequency in weeks 3 and 4 post-treatment. RESULTS: A total of 11 AEs were 
      registered. There was one severe adverse event (SAE): posterior epistaxis. The 
      number of cluster headache attacks (main efficacy outcome) was statistically 
      significantly reduced in the intention-to-treat analysis from 18 +/- 12 per week in 
      baseline to 11 +/- 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had 
      at least 50% reduction of attack frequency compared to baseline. The cluster 
      attack frequency was significantly reduced for five out of six months 
      post-treatment. CONCLUSION: Randomised, placebo-controlled studies are warranted 
      to establish the potential of this possible novel treatment of cluster headache.
CI  - (c) International Headache Society 2015.
FAU - Bratbak, Daniel Fossum
AU  - Bratbak DF
AD  - Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, 
      Norway Department of Neuroscience, Norwegian University of Science and 
      Technology, Norway daniel.f.bratbak@ntnu.no.
FAU - Nordgard, Stale
AU  - Nordgard S
AD  - Department of Neuroscience, Norwegian University of Science and Technology, 
      Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, 
      Norway.
FAU - Stovner, Lars Jacob
AU  - Stovner LJ
AD  - Department of Neuroscience, Norwegian University of Science and Technology, 
      Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim 
      University Hospital, Norway.
FAU - Linde, Mattias
AU  - Linde M
AD  - Department of Neuroscience, Norwegian University of Science and Technology, 
      Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim 
      University Hospital, Norway Department of Neurology, St. Olavs Hospital, 
      Trondheim University Hospital, Norway.
FAU - Folvik, Mari
AU  - Folvik M
AD  - Department of Radiology, St. Olavs Hospital, Trondheim University Hospital, 
      Norway.
FAU - Bugten, Vegard
AU  - Bugten V
AD  - Department of Neuroscience, Norwegian University of Science and Technology, 
      Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, 
      Norway.
FAU - Tronvik, Erling
AU  - Tronvik E
AD  - Department of Neuroscience, Norwegian University of Science and Technology, 
      Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim 
      University Hospital, Norway Department of Neurology, St. Olavs Hospital, 
      Trondheim University Hospital, Norway.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20150731
PL  - England
TA  - Cephalalgia
JT  - Cephalalgia : an international journal of headache
JID - 8200710
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects
MH  - Cluster Headache/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/*administration & dosage/adverse effects
MH  - Neuronavigation
MH  - Pain, Intractable/*drug therapy
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Sphenopalatine Ganglion Block/adverse effects/*methods
MH  - Treatment Outcome
PMC - PMC4853809
OTO - NOTNLM
OT  - Cluster headache
OT  - botulinum toxin
OT  - headache
OT  - pterygopalatine ganglion
OT  - sphenopalatine ganglion
EDAT- 2015/08/02 06:00
MHDA- 2017/03/16 06:00
PMCR- 2016/05/03
CRDT- 2015/08/02 06:00
PHST- 2015/06/26 00:00 [received]
PHST- 2015/07/04 00:00 [accepted]
PHST- 2015/08/02 06:00 [entrez]
PHST- 2015/08/02 06:00 [pubmed]
PHST- 2017/03/16 06:00 [medline]
PHST- 2016/05/03 00:00 [pmc-release]
AID - 0333102415597891 [pii]
AID - 10.1177_0333102415597891 [pii]
AID - 10.1177/0333102415597891 [doi]
PST - ppublish
SO  - Cephalalgia. 2016 May;36(6):503-9. doi: 10.1177/0333102415597891. Epub 2015 Jul 
      31.