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Study identifier: NCT03944876 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

Condition: Cluster Headache  ·  Sponsor: Norwegian University of Science and Technology

PhasePhase 3
Planned participants112
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNo

About this study

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

This description comes directly from the study's public registry record.

Talk to the study team

Tore Wergeland Meisingset, md phd  ·  +47 728 21 335  ·  tore.w.meisingset@ntnu.no

Erling Tronvik, md phd  ·  erling.tronvik@ntnu.no

Always discuss trial participation with your own doctor first.

Locations (5)

Praxisklinik UlmenhofHamburg, GermanyRecruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI)Milan, ItalyRecruiting
St Olavs HospitalTrondheim, NorwayRecruiting
Department of Neurology, University Clinic Hospital. Catholic University of ValenciaValencia, SpainRecruiting
National Hospital of Neurology and Neurosurgery, University College of LondonLondon, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT03944876