Botox Injection in Treatment of Chronic Migraine

NCT ID: NCT02259075

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum Toxin

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.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Interventions

Botulinum Toxin Type A

Intervention Type: DRUG

Other Intervention Names

Botox; BTA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erling A Tronvik, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 27154997 (View on PubMed)

Other Identifiers

2014-001852-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BTACM2014

Identifier Type: -

Identifier Source: org_study_id