RecruitingPhase 3NCT03944876

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


Sponsor

Norwegian University of Science and Technology

Enrollment

112 participants

Start Date

Nov 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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 .


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Botulinum toxin type A and a drug called placebo for people with cluster headache. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBotulinum toxin type A

Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

DRUGplacebo

0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)


Locations(5)

Praxisklinik Ulmenhof

Hamburg, Germany

Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI)

Milan, Italy

St Olavs Hospital

Trondheim, Norway

Department of Neurology, University Clinic Hospital. Catholic University of Valencia

Valencia, Spain

National Hospital of Neurology and Neurosurgery, University College of London

London, United Kingdom

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NCT03944876


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