Chronic cluster headache
Conditions
Sponsors
NTNU- Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed and written consent. 2. Male or female, 18-85 years of age 3. Headache attacks fulfilling the International Classification of Headache Disorders (ICHD) III criteria for chronic cluster headache (CCH) 3.1.2. 4. Dominant headache laterality with = 80% of cluster headache attacks on one side. 5. Subject reports an average of = 4 cluster attacks/week on the side of their dominant headache laterality in the 3 months prior to inclusion and in the baseline period. 6. The condition is pharmacologically refractory defined as suboptimal effect or intolerable side effects or contraindication for verapamil or lithium or suboccipital steroid injection. 7. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period. 8. Subject is able to differentiate concomitant headaches from cluster headache. 9. In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception in a period of 4 weeks after injection. 10. Ability to understand study procedures and to comply with them for the entire length of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Subject has had a change in type, dosage or dose frequency of preventive headache medications = two weeks prior to baseline/screening or 5 half-lives, whichever is longer.1 2. Subject currently treated with occipital nerve stimulation, deep brain stimulation or other implantable device, that have changed parameters in the last month, or are unable to keep parameters stable throughout the study. 3. Current or previous treatment with implanted medical devices targeting the SPG 4. Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period, eg. prior to IMP administration. 5. Non-responder to both oxygen and triptan. 6. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer. 7. Subject is currently participating or has participated in the last 3 months in another clinical study in which the subject has, is, or will be exposed to an investigational or non- Basic Study Protocol, Version 3.0, 18.06.2023 17 investigational drug or device. 8. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances. 9. Abuse of drugs or alcohol. 10. Use of opioids for =10 days per month. 11. Treatment with pharmacological substances that may interact with BTA (aminoglycosids, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinestases.). 12. WOCBP that do not adhere to the requirements for HEC, as noted in inclusion criteria 9 and outlined in section 3.3. 13. Pregnancy or breastfeeding in the study period 14. Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned injection site that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure. 15. Facial anomaly or trauma which renders the procedure difficult.2 16. Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms. 17. Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months. 18. Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator. 19. Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator. 20. Patient with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection. 21. Patient with disorders that are known contraindication for Botox® treatment, especially neuromuscular disorders such as motorneuron disorders and myasthenic syndromes 22. Subject has had previous radiofrequency ablation, balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the ipsilateral trigeminal ganglion or any branch of the trigeminal nerve. 23. Subject has had previous radiofrequency ablation (including non-lesiona
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy of treatment with botulinum toxin towards the sphenopalatine ganglion (SPG) in treatment refractory chronic cluster headache using an image-guided surgical device (MultiGuide).;Secondary Objective: Secondary objectives are safety, feasibility, number of responders, acceptability of treatment, cluster headache attack features (intensity, autonomic symptoms, duration), use of acute medication and quality of life measures.;Primary end point(s): Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5 – 8 post-intervention in the treatment group versus the placebo group.;Timepoint(s) of evaluation of this end point: After unblinding at study end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference in occurrence of AEs and SAEs in the active group versus the placebo group 2. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group 3. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5-8 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 3.1. In the high and the low frequency subgroups 3.2. In the high and the low frequency variation subgroups 4. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 4.1. In the high and the low frequency subgroups 4.2. In the high and the low frequency variation subgroups 5. Difference in the number of therapeutic responders (= 30% reduction in attack frequency, intensity or both during weeks 5 – 8 post-intervention compared to baseline) in the active group versus the placebo group. 5.1. In the entire randomized population 5.2. In the high and the low frequency subgroups 5.3. In the high and the low frequency variation subgroups 6. Difference in the number of attack frequency responders (= 30% reduction in attack frequency during weeks 5 – 8 post-intervention compared to baseline). 6.1. In the entire randomized population 6.2. In the high and the low frequency subgroups 6.3. In the high and the low frequency variation subgroups 7. Difference in change from baseline week 5-8 in mean attack intensity week 5 – 8 post-intervention in the active group versus the placebo group. 7.1. In the entire randomized population 7.2. In the high and the low frequency subgroups 7.3. In the high and the low frequency variation subgroups;Timepoint(s) of evaluation of this end point: After unblinding at study end. | — |
Countries
Germany, Italy, Norway, Spain, United Kingdom
Contacts
Public ContactDep. of Neuromedicine and Movement
NTNU, Norwegian University of Science and Technology
Outcome results
None listed