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

NCT03543254 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2017/14902017-002516-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders; Chronic Disease

Keywords

Botulinum Toxins, Type A; Injections; Cranial Sutures; Head

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  adverse events (other than clearly related to migraine) will be recorded in the diary by the patients and reviewed during the scheduled visits

  12 weeks

Secondary Outcomes (1)

• Injection Time

  Week 1

Study Arms (1)

BoNT-A injected

EXPERIMENTAL

BoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration

Drug: BoNT-A

Interventions

BoNT-A DRUG

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.

Also known as: Botox, Botulinum Toxin Type A

BoNT-A injected

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic migraine, as defined in the ICHD-3 beta version
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Stovner LJ, Hagen K, Tronvik E, Bruvik Gravdahl G, Burstein R, Dodick DW. FollowTheSutures: Piloting a new way to administer onabotulinumtoxinA for chronic migraine. Cephalalgia. 2022 Jun;42(7):590-597. doi: 10.1177/03331024211067775. Epub 2022 Feb 15.

  PMID: 35166150 DERIVED

Related Links

• Published paper in Cehalalgia

MeSH Terms

Conditions

Migraine Disorders; Chronic Disease

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Knut Hagen
• Organization: St. Olavs Hospital HF

knut.hagen@ntnu.no

+4795401579

Study Officials

• Geir Bråthen, md

  St. Olavs Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)