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
N/A
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 condition causing repeated intense one-sided headaches, which can be episodic or chronic. The study evaluates whether a precise injection of botulinum toxin type A targeting the sphenopalatine ganglion (SPG), a nerve area involved in pain attacks, can reduce the frequency of attacks in patients with chronic cluster headache. This is a randomized, placebo-controlled, triple-blinded Phase 3 trial to explore this treatment approach further based on earlier promising phase 1/2 results. Participants receive either a single injection of botulinum toxin type A or a placebo injection, both targeted at the SPG on the headache side of the face, using the Multiguide navigation system for precise delivery. The botulinum toxin dose is 25 Allergan units in 0.5 ml sodium chloride, compared with 0.5 ml sodium chloride alone for the placebo group. The study compares changes in headache attack frequency and intensity during weeks 5 to 8 and weeks 9 to 12 after injection. Throughout the study, participants are monitored for changes in the number and intensity of cluster headache attacks, as well as any adverse events. The primary outcome is the difference in average weekly attacks between weeks 5 and 8 post-injection compared to baseline. Secondary outcomes include safety assessments and responses in predefined subgroups. The study lasts through 12 weeks post-injection, with careful adherence to current headache medications and contraception requirements for women of childbearing potential.
CONDITIONS
Brief 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...
- Provide informed, written consent.
- Male or female aged 18 to 85 years.
- Diagnosed with chronic cluster headache according to official criteria (ICHD III 3.1.2).
- Experience at least 80% of cluster headache attacks on one side.
- Average of 4 or more cluster attacks per week on the dominant headache side in the 3 months before inclusion and during baseline.
- Condition is pharmacologically refractory with suboptimal effect or intolerable side effects or contraindications to verapamil, lithium, or suboccipital steroid injection.
- Agree to keep current preventive headache medications unchanged during the study.
- Able to distinguish cluster headaches from other headache types.
- 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 period.
You will not qualify if you...
- Changed preventive headache medication type, dose, or frequency within 2 weeks before baseline or 5 half-lives, whichever is longer.
- Use of occipital nerve stimulation, deep brain stimulation, or implantable devices with recent parameter changes or inability to keep stable during the study.
- Current or previous treatment with implanted devices targeting the sphenopalatine ganglion.
- Change in preventive headache medications during baseline period.
- Non-responder to both oxygen and triptan treatments.
- Participation in another clinical trial with new drugs within 2 months or 5 half-lives.
- Participation in any clinical study with investigational or non-investigational drugs/devices within last 3 months.
- Allergy or hypersensitivity to marcaine, lidocaine, xylocaine, adrenaline, botulinum toxin, or similar substances.
- Substance abuse or opioid use for 10 or more days per month.
- Treatment with substances that may interact with botulinum toxin A.
- Women of childbearing potential not using effective contraception.
- Pregnancy or breastfeeding during the study.
- Facial surgery or anomalies affecting injection procedure.
- Active oral/dental infection at injection site.
- Recent malignancy or major infections involving the face within 6 months.
- High comorbidity or frailty reducing life expectancy or compliance.
- Psychiatric disorders affecting study compliance.
- Active infectious diseases requiring special control measures.
- Neuromuscular disorders contraindicating botulinum toxin use.
- Previous destructive procedures to trigeminal or sphenopalatine ganglia.
- Recent short-acting anesthetic blocks of the sphenopalatine ganglion.
- Recent onabotulinumtoxinA injections to head/neck.
- Anticipated need for excluded medications or procedures during study.
- History of bleeding or coagulopathy disorders.
- Inability to stop antithrombotic medications before procedure.
- Diagnosis of other trigeminal autonomic cephalalgia or trigeminal neuralgia.
- Mentally or legally incapacitated or unable to consent.
- Study center employees or relatives involved in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One-time injection with follow-up to 12 weeks post-injection
Participants receive a single injection of either Botulinum toxin type A or placebo targeted at the sphenopalatine ganglion on the headache side of the face.
1 injection visit and weekly visits for up to 12 weeks
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
E
Erling Tronvik, md phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here