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Botox Injection in Treatment of Chronic Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neuroscience, Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botulinum Toxin

Arm 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.

Outcomes

Primary Outcome Measures

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.
Number of headache days with moderate or severe intensity
measured from week 5 to week 8, in total during 4 weeks

Secondary Outcome Measures

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)
Days with moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12
Days without headache per 4 weeks
week 1-4, week 5-8, week 9-12
Hours with headache of moderate or severe headache per 4 weeks
week 1-4, week 5-8, week 9-12

Full Information

First Posted
October 3, 2014
Last Updated
May 20, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02259075
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine with aura, Migraine without aura, Headache disorders, Botulinum Toxin Type A, Sphenopalatine Ganglion Block, Autonomic Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox, BTA
Primary Outcome Measure Information:
Title
Number of adverse events and number of participants with adverse events
Description
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.
Time Frame
For the follow-up period of 3 months
Title
Number of headache days with moderate or severe intensity
Description
measured from week 5 to week 8, in total during 4 weeks
Time Frame
5-8 weeks
Secondary Outcome Measure Information:
Title
Number of reponders
Description
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)
Time Frame
12 weeks
Title
Days with moderate or severe headache per 4 weeks
Description
week 1-4, week 5-8, week 9-12
Time Frame
12 weeks
Title
Days without headache per 4 weeks
Description
week 1-4, week 5-8, week 9-12
Time Frame
12 weeks
Title
Hours with headache of moderate or severe headache per 4 weeks
Description
week 1-4, week 5-8, week 9-12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling A Tronvik, PhD, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroscience, Norwegian University of Science and Technology
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27154997
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.
Results Reference
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Botox Injection in Treatment of Chronic Migraine

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