Botox Injection in Treatment of Chronic Migraine

Study Overview
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Brief Summary
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Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect. The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion. The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail. The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.

Official Title
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Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed and written consent Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria Failed at least 3 oral migraine prophylactic treatments Duration of migraine at least 1 year before inclusion Start of migraine before participant turned 50 years Participant can make a distinction between migraine and other types of headache Exclusion Criteria: If the criteria for medication-overuse headache (MOH) is fulfilled 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 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 Anomalies which hinder or impede the used method of injection 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: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin<br>The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU. | Drug: Botulinum Toxin Type A<br> <br> * Other names: BTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and number of participants with adverse events | 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 by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations. | For the follow-up period of 3 months | 
| Number of headache days with moderate or severe intensity | measured from week 5 to week 8, in total during 4 weeks | 5-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of reponders | response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12) | 12 weeks | 
| Days with moderate or severe headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | 
| Days without headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | 
| Hours with headache of moderate or severe headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block