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

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ClinicalTrials.gov Identifier: NCT03543254
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
Mayo Clinic
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Chronic Disease Drug: BoNT-A Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine

Arm Intervention/treatment
Experimental: BoNT-A injected
BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration
Drug: BoNT-A

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.

Other Names:
  • Botox
  • Botulinum Toxin Type A




Primary Outcome Measures :
  1. number of adverse events [ Time Frame: 12 weeks ]
    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 :
  1. moderate-severe headache days 5-8 weeks after injection compared with baseline [ Time Frame: 8 weeks ]
    course of headache is recorded in the headache diary before and after injection



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543254


Contacts
Contact: Lars Jacob Stovner, md prof +47 72575070 lars.stovner@ntnu.no

Locations
United States, Arizona
Mayo Clinic, 13400 E. Shea Blvd Recruiting
Scottsdale, Arizona, United States, 85259
Contact: David Dodick, md prof    480-301-8000    dodick.david@mayo.edu   
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Lars Jacob Stovner, md prof    +47 : 72575070 / 97136611    lars.stovner@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Mayo Clinic
Investigators
Study Director: Geir Bråthen, md St. Olavs Hospital

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03543254     History of Changes
Other Study ID Numbers: 2017/1490
2017-002516-13 ( EudraCT Number )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

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

Keywords provided by Norwegian University of Science and Technology:
Botulinum Toxins, Type A
Injections
Cranial Sutures
Head

Additional relevant MeSH terms:
Migraine Disorders
Chronic Disease
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disease Attributes
Pathologic Processes
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents