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

Launched by NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · May 31, 2018

Keywords

ClinConnect Summary

The study is an an open-label, non-con trolled, single-arm and single-center phase II study, at the outpatient clinic of the Department of Neurology and Clinical neurophysiology at St. Olavs Hospital, Trondheim, Norway. The study was originally also planned at the Mayo Clinic, Scottsdale, AZ, USA, but because the study there had not been started before the COVID-19 pandemic, the study was performed only in Trondheim. Potential study participants should be identified among the regular outpatients at the Department of Neurology at St. Olavs hospital. Potential participants should recceive an ...

Gender

ALL

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).