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Migraine DisordersPhase 2NCT03543254

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

A Phase 2 study testing BoNT-A in people with Migraine Disorders and Chronic Disease, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Migraine Disorders, Chronic Disease
What is being tested?
BoNT-A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNorway
Study dates
1 May 2018to 1 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • St Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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.

Read the detailed description

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 email with the informed consent form, which should be signed at the screening visit where a detailed medical history and medical examination should be per formed. Patients should complete a paper head ache diary, recording pain intensity and duration, concomitant migraine symptoms (nausea, vomiting, phono- and photophobia), acute medication (type, number of doses) and work absence (yes/no/not relevant). Also, they should record any adverse events. After 7-14 days, they should receive a telephone call from a nurse asking about adverse events and concom itant medication and reminding them to maintain the daily diary. After a baseline period of at least 28 days, diaries should be reviewed at a treatment visit, and each participant should receive injections according to the described procedure. Women of child bearing potential should have a negative pregnancy test before the injections. The duration of the injection procedure should be measure with a stopwatch and immediately after the injections, the patient should be asked to record on a VAS scale (0-10) the level of pain of the procedure and the investigator recorded the degree of bleeding (no, mild, moderate, marked) and any other injection-related adverse events (AEs). Patients should then be asked were asked to keep a headache diary for another 12 weeks or more, before the end of the study visit. During this period, they should receive a call from the study nurse at weeks 2 and 9, reminding to keep the headache diary, and asking about AEs and concomitant medication. They should be also asked whether they had noticed any change in their ability to make forehead wrinkles (no, little, moderate, marked, full paralysis)

Being tested
BoNT-A
Keywords
Botulinum Toxins, Type A, Injections, Cranial Sutures, Head
Medical subject headings
Migraine Disorders, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BoNT-ADrug

    Also called Botox, Botulinum Toxin Type 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.

Study groups in NCT03543254
Study groupRoleWhat they receive
BoNT-A injectedExperimentalBoNT-A (Botulinum toxin A) injected in the head on specific sites and in half the usual concentration
Receives: Drug: BoNT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Injection Time

    Time used for injection of Medicine measured by stopwatch

    Measured: Week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2018
  2. Study start1 May 2018
  3. Primary completion1 Jan 2021
  4. Study completion1 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03543254
Sponsor's protocol ID
2017/1490
Other IDs
2017-002516-13, 2017
Status last verified
Jan 2024
First submitted
18 May 2018
Last updated
30 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plans

Publications

  • 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.

    PubMed 35166150

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BoNT-A in people with Migraine Disorders and Chronic Disease, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03543254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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