"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

2017/1490

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.

2018-05-01

2021-01-01

2021-01-01

Completed

Early phase I

20

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).

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2024-01-30