Botox Injection in Treatment of Chronic Migraine

NCT02259075 | Completed Phase 1 DMC

• 2 other identifiers: BTACM20142014-001852-43
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Migraine with aura; Migraine without aura; Headache disorders; Botulinum Toxin Type A; Sphenopalatine Ganglion Block; Autonomic Nerve Block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of reponders

  12 weeks

• Days with moderate or severe headache per 4 weeks

  12 weeks

• Days without headache per 4 weeks

  12 weeks

• Hours with headache of moderate or severe headache per 4 weeks

  12 weeks

Study Arms (1)

Botulinum Toxin

EXPERIMENTAL

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

Interventions

Botulinum Toxin Type A DRUG

Also known as: Botox, BTA

Botulinum Toxin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Start of migraine before participant turned 50 years
• Participant can make a distinction between migraine and other types of headache

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 27154997 RESULT

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Erling A Tronvik, PhD, MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

NO (1)