Actively Recruiting
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache
Led by Norwegian University of Science and Technology · Updated on 2024-11-19
112
Participants Needed
5
Research Sites
304 weeks
Total Duration
On this page
Sponsors
N
Norwegian University of Science and Technology
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed and written consent
- Male or female aged 18 to 85 years
- Headache attacks meeting the criteria for chronic cluster headache
- Predominant headache on one side with at least 80% of attacks on that side
- Average of 4 or more cluster attacks per week on the dominant side during the 3 months before inclusion and baseline
- Condition is resistant to medications like verapamil, lithium, or suboccipital steroid injections
- Agrees to keep current preventive headache medication unchanged during the study
- Able to distinguish cluster headaches from other headaches
- Women of childbearing potential must use highly effective contraception for 4 weeks after injection
- Able to understand and comply with study procedures throughout the study
You will not qualify if you...
- Changed preventive headache medication type or dose within 2 weeks before baseline or during baseline period
- Currently using or recently changed parameters of implantable devices like occipital nerve or deep brain stimulators
- Previously treated with implanted devices targeting the sphenopalatine ganglion
- Non-responder to oxygen and triptan treatments
- Participated in other clinical trials recently or currently
- Allergic to botulinum toxin or related substances
- History of drug or alcohol abuse
- Use of opioids for 10 or more days per month
- Use of medications that may interact with botulinum toxin
- Women of childbearing potential not meeting contraception requirements
- Pregnancy or breastfeeding during the study
- Past facial surgery or trauma affecting injection area
- Active infections or abscesses at injection site
- Recent malignancies or infectious diseases requiring special control
- Significant other illnesses or psychiatric disorders affecting compliance
- History of bleeding or clotting disorders
- Unable to stop blood-thinning medications before procedure
- Diagnosed with other trigeminal nerve conditions
- Mentally incapacitated or unable to consent
- Study center employees involved in the trial or their relatives
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Praxisklinik Ulmenhof
Hamburg, Germany
Actively Recruiting
2
Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI)
Milan, Italy
Actively Recruiting
3
St Olavs Hospital
Trondheim, Norway
Actively Recruiting
4
Department of Neurology, University Clinic Hospital. Catholic University of Valencia
Valencia, Spain
Actively Recruiting
5
National Hospital of Neurology and Neurosurgery, University College of London
London, United Kingdom
Actively Recruiting
Research Team
T
Tore Wergeland Meisingset, md phd
CONTACT
E
Erling Tronvik, md phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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