Back to results"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
Primary Purpose
Migraine Disorders, Chronic Disease
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
BoNT-A
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Botulinum Toxins, Type A, Injections, Cranial Sutures, Head
Eligibility Criteria
Inclusion Criteria:
- Chronic migraine, as defined in the ICHD-3 beta version
- Chronic migraine should have been present for at least ½ year prior to evaluation for study inclusion
- For women of child-bearing potential there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion Criteria:
- Diseases that are contraindications for use of Botulinum toxin A (Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, other diseases interfering with neuromuscular function)
- Allergy to Botulinum toxin A
- Other primary or secondary headache disorder, including medication overuse headache (MOH). This means that at least one attempt to withdraw acute medication should have been performed earlier, but without success
- Severe depression or other psychiatric disorder that may interfere with the treatment
- Abuse of alcohol or illicit drugs
- Use of more than one headache prophylactic medication, or change in type and dose of prophylactic medication < 28 days before start of baseline period
- Previous exposure at any time to any botulinum toxin serotype
- Infection at one or more injection site(s)
- Having received extracranial nerve block, cervical facet injection, or other interventional procedure for headache within the prior 3 months
- Use of opioids or barbiturate containing medication(s) > 10 days per month within the preceding 3 months
- Participating in another trial that might affect the current study
- Should not participate in the opinion of the investigator (e.g. not able to comply with study procedures).
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BoNT-A injected
Arm Description
BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration
Outcomes
Primary Outcome Measures
number of adverse events
adverse events (other than clearly related to migraine) will be recorded in the diary by the patients and reviewed during the scheduled visits
Secondary Outcome Measures
moderate-severe headache days 5-8 weeks after injection compared with baseline
course of headache is recorded in the headache diary before and after injection
Full Information
NCT ID
NCT03543254
First Posted
May 18, 2018
Last Updated
March 18, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03543254
Brief Title
"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
Official Title
"Follow the Sutures". An Open Multicenter, Multinational Pilot Study to Explore Tolerability, Safety and Effect of a New Procedure for Injecting Botulinum Toxin in the Head Against Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is no doubt that chronic migraine is a large public health problem, which is both disabling and costly. Many patients and headache doctors see Botulinum toxin (Botox) treatment as a big stride forward, but it is a problem that the effect has been shown in only one study, with a low therapeutic gain. For this reason, before this costly treatment is expanded to potentially several thousand patients in Norway, it would be highly desirable that 1) there is additional good scientific evidence for use of Botox , 2) a more effective treatment procedure is developed, 3) the potential for unblinding is reduced, and 4) the dose, number of injection sites and cost can be halved, and 5) the adverse effects are minimized. These may be the results of this pilot project where injections are given along the sutures, which can open up for a later randomized, blinded and controlled study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Chronic Disease
Keywords
Botulinum Toxins, Type A, Injections, Cranial Sutures, Head
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BoNT-A injected
Arm Type
Experimental
Arm Description
BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration
Intervention Type
Drug
Intervention Name(s)
BoNT-A
Other Intervention Name(s)
Botox, Botulinum Toxin Type A
Intervention Description
90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull.
First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures.
Primary Outcome Measure Information:
Title
number of adverse events
Description
adverse events (other than clearly related to migraine) will be recorded in the diary by the patients and reviewed during the scheduled visits
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
moderate-severe headache days 5-8 weeks after injection compared with baseline
Description
course of headache is recorded in the headache diary before and after injection
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic migraine, as defined in the ICHD-3 beta version
Chronic migraine should have been present for at least ½ year prior to evaluation for study inclusion
For women of child-bearing potential there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception
Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion Criteria:
Diseases that are contraindications for use of Botulinum toxin A (Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, other diseases interfering with neuromuscular function)
Allergy to Botulinum toxin A
Other primary or secondary headache disorder, including medication overuse headache (MOH). This means that at least one attempt to withdraw acute medication should have been performed earlier, but without success
Severe depression or other psychiatric disorder that may interfere with the treatment
Abuse of alcohol or illicit drugs
Use of more than one headache prophylactic medication, or change in type and dose of prophylactic medication < 28 days before start of baseline period
Previous exposure at any time to any botulinum toxin serotype
Infection at one or more injection site(s)
Having received extracranial nerve block, cervical facet injection, or other interventional procedure for headache within the prior 3 months
Use of opioids or barbiturate containing medication(s) > 10 days per month within the preceding 3 months
Participating in another trial that might affect the current study
Should not participate in the opinion of the investigator (e.g. not able to comply with study procedures).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Bråthen, md
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
35166150
Citation
Stovner LJ, Hagen K, Tronvik E, Bruvik Gravdahl G, Burstein R, Dodick DW. FollowTheSutures: Piloting a new way to administer onabotulinumtoxinA for chronic migraine. Cephalalgia. 2022 Jun;42(7):590-597. doi: 10.1177/03331024211067775. Epub 2022 Feb 15.
Results Reference
derived
Learn more about this trial
"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
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