Botulinum toxin type A block of the otic ganglion in chronic cluster headache. Safety issues.

Department of Neuroscience, NT0 个研究点目标入组 10 人开始时间: 2017年2月1日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•1.Written consent from the patient
•2.Age 18 to 70 years old
•3.Patient fulfilling ICHD-3 Beta criteria for chronic cluster headache (27)
•4.Mean attack frequency of four attacks per week or more.
•5.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 four weeks before entering the baseline period throughout the duration of the study.
•6.The patient has an intractable cluster headache. Silberstein et al. (28) have defined moderate intractability” as failing at least two drugs. Patients that will be included had unsatisfactory effect, intolerable side effects or contraindication of at least two of the following medications:
•suboccipital steroid injection
•7.The patient is able to distinguish between cluster headache attacks and other types of headache
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Modification or addition of any prophylactic drug dose used against cluster headache in the last 4 weeks before inclusion or during the trial.
•2.Use of antipsychotic medication in the last 4 weeks before inclusion
•3.Concomitant significant heart or lung diseases
•4.Systemic or local conditions, which can increase the risk of the procedure
•5.Psychiatric or psychological conditions interfering with the participation in the study
•6.Pregnancy
•7.Breast feeding
•8.Inadequate contraceptive use
•9.Opioid overuse
•10. Abuse of drugs, including alcohol
•11. Allergy or hypersensitivity reaction to marcain, lidocain, xylocain, adrenalin or related drugs.
•12. Anatomical variants which might impede the study treatment
•13. Known hypersensitivity to botulinum toxin type A or any of the excipients found in Botox®.
•14. Current treatment with drugs which have interactions with botulinum toxin: aminoglycosids, spectinomycin, neuromuscular blockers, both depolarizing agents (such as sucsinylcholine) or non depolarizing (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinestases.
•15.Previous cerebral ischemic infarction.
•16. Not able to take MRI
•17. Previous destructive surgery or interventional procedures involving the C2 or C3 roots (vertebrae), SPG, any extracranial nerve, trigeminal nerve, or deep brain stimulation

发起方

Department of Neuroscience, NT