Botox Injection in Treatment of Chronic Migraine

Norwegian University of Science and Technology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Migraine Disorders

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02259075

2014-001852-43 (EudraCT Number)

BTACM2014

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Botulinum Toxin

Experimental group

Description:

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.

Treatment:

Drug: Botulinum Toxin Type A