Clinical trial NCT02259075: Botox Injection in Treatment of Chronic Migraine
Official title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Migraine Disorders
Keywords: Migraine with aura
Migraine without aura
Headache disorders
Botulinum Toxin Type A
Sphenopalatine Ganglion Block
Autonomic Nerve Block
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events and number of participants with adverse events
timeFrame: For the follow-up period of 3 months
measure: Number of headache days with moderate or severe intensity
timeFrame: 5-8 weeks
Secondary outcomes:
measure: Number of reponders
timeFrame: 12 weeks
measure: Days with moderate or severe headache per 4 weeks
timeFrame: 12 weeks
measure: Days without headache per 4 weeks
timeFrame: 12 weeks
measure: Hours with headache of moderate or severe headache per 4 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Erling A Tronvik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bratbak DF, Nordgard S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2017 Apr;37(4):356-364. doi: 10.1177/0333102416648328. Epub 2016 May 6.