"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT03543254
• Date of registration: 18/05/2018
• Prospective Registration: Yes
• Primary sponsor: Norwegian University of Science and Technology
• Public title: "Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
• Scientific 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
• Date of first enrolment: June 1, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03543254
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Norway, United States

Contacts

• Name: Geir Bråthen, md
• Affiliation: St. Olavs Hospital

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Disease

Migraine Disorders

Intervention(s)

Drug: BoNT-A

Primary Outcome(s)

number of adverse events [Time Frame: 12 weeks]

Secondary Outcome(s)

moderate-severe headache days 5-8 weeks after injection compared with baseline [Time Frame: 8 weeks]

Secondary ID(s)

2017/1490

2017-002516-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital

Mayo Clinic