"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
Condition: Migraine Disorders; Chronic Disease
MeSH terms: Migraine Disorders; Chronic Disease
Intervention: BoNT-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.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Botulinum Toxins, Type A; Injections; Cranial Sutures; Head

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.
    

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).