Cluster headache
Conditions
Interventions
Trade Name: Botox
Product Name: Botox
Product Code: M03AX01
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
Department of Neuroscience, NTNU
Eligibility
Inclusion criteria
Inclusion criteria: 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: • verapamil • lithium • 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety;Secondary Objective: To evaluate the effect of the treatment;Primary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: For the follow-up period of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of cluster headache attacks per week • Duration of cluster headache attacks • Days without cluster headache attacks • Headache intensity (scale 0-5) • Mean intensity per attack • Mean number of attacks with intensity grade 4 and 5 • Functional level • Triptan use per 4 weeks • Number of analgesic doses per 4 weeks • Absenteeism due to cluster headache • Qualitative questionnaire • HIT-6 • Occurrence of autonomic symptoms (CAPS scale). • WHO Performance status;Timepoint(s) of evaluation of this end point: Average from baseline compared to average of week 5-8 | — |
Countries
Norway
Contacts
Public ContactLars Jacob Stovner
Department of Neuroscience, NTNU
Outcome results
None listed