Botox Injection in Treatment of Cluster Headache

Study Overview
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Brief Summary
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Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. The headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. For a small group of patients with episodic and most chronic form, drug therapy has little effect. For them, surgery can be a solution. Neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. Furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. The duration of such a blockade is believed to be 3-9 months. The purpose of the present study is to develop and evaluate a new surgical procedure with injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure. The main objective of the project is to determine the safety of BTA injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. Secondary objectives are to identify the changes of headache attacks by the method used.

Official Title
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Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues

Conditions
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Cluster Headache

Intervention / Treatment
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* Drug: Botulinum Toxin Type A 25 IU
* Drug: Botulinum Toxin Type A 50 IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed and written consent Cluster headaches defined in ICHD-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment Exclusion Criteria: Heart or lung disease Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia Psychiatric illness that hinders participation in the study Known pregnancy or breast feeding Inadequate use of contraceptives Overuse or abuse of opioids Abuse of medications, narcotics or alcohol Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication Treatment with medication that can interact with botulinum toxin type A

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin Type A 25 IU<br>The first five patients will be injected 25 IU of Botulinum Toxin Type A | Drug: Botulinum Toxin Type A 25 IU<br> <br> * Other names: Botox;|
| Experimental: Botulinum Toxin Type A 50 IU<br>the next five patients will receive 50 IU of Botulinum Toxin Type A | Drug: Botulinum Toxin Type A 50 IU<br> <br> * Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety | Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events. Registration of any adverse events categorized by probable relationship to drug, the surgical procedure or anesthesia. Data obtained from the headache diaries as well as open questions during consultations. | For the follow-up period of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster headache attack frequency |  | Average number of attacks of baseline compared to average of week 3 and 4 after injection | 
| Hours with cluster headache |  | Average of baseline compared to average of week 3 and 4 after injection | 
| Days with cluster headache |  | Average of baseline compared to average of week 3 and 4 after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Headache, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block