Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT03066635
Eligibility Criteria:
Inclusion Criteria:
* Informed and written consent
* Fulfilling International Classification of Headache Disorders (ICHD) -3 Beta criteria for chronic cluster headache
* Mean attack frequency of four attacks per week or more
* Agreeing to refrain from starting new prophylactic cluster headache medication, including steroids, or any other therapy aimed at cluster headache, and agreeing to maintain existing prophylactic cluster headache medication from 4 weeks before entering the baseline period throughout the duration of the study
* Intractable cluster headache, i.e. unsatisfactory effect, intolerable side effects or contraindication of at least 2 of the following medications: Verapamil, Lithium, Suboccipital steroid injection,
* Able to distinguish between cluster headache attacks and other types of headache.
Exclusion Criteria:
* Modification or addition of any prophylactic drug dose used against cluster headache in the last 4 weeks before inclusion of during the trial
* Use of antipsychotic medication in the last 4 weeks before inclusion
* Concomitant significant heart or lung disease
* Systemic or local conditions which can increase the risk of the procedure
* Psychiatric or psychological conditions interfering with the participation in the study
* Pregnancy
* Breast feeding
* Inadequate use of contraceptives
* Opioid overuse
* Abuse of drugs including alcohol
* Anatomical variants which might impede the study treatment
* Known hypersensitivity to botulinum toxin type A or any of the excipients found in Botox
* Current treatment with drugs that interact with botulinum toxin: aminoglycosides, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing agents (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinesterases.
* Previous cerebral ischemic infarction
* Not able to take magnetic resonance imaging (MRI)
* Previous destructive surgery of interventional procedures involving the C2 and C3 roots (vertebrae), sphenopalatine ganglion, any extracranial nerve, trigeminal nerve, or deep brain stimulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03066635
Study Brief:
Protocol Section:
NCT03066635