Botox Injection in Treatment of Chronic Migraine

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259075
• Other study ID #: BTACM2014
• Secondary ID: 2014-001852-43
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2014
• Last updated: May 20, 2016
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Botulinum Toxin Type A

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bratbak DF, Nordgård 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. 2016 May 6. pii: 0333102416648328. [Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Number of headache days with moderate or severe intensity	measured from week 5 to week 8, in total during 4 weeks	5-8 weeks	No
Secondary	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	No
Secondary	Days with moderate or severe headache per 4 weeks	week 1-4, week 5-8, week 9-12	12 weeks	No
Secondary	Days without headache per 4 weeks	week 1-4, week 5-8, week 9-12	12 weeks	No
Secondary	Hours with headache of moderate or severe headache per 4 weeks	week 1-4, week 5-8, week 9-12	12 weeks	No