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Can a targeted botox shot quiet the Brain's pain center for chronic migraine?

NCT ID NCT04069897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial investigates whether injecting Botox near a nerve bundle in the face, called the sphenopalatine ganglion, can reduce the number of severe headache days in people with chronic migraine that hasn't improved with other treatments. Participants receive either Botox or a placebo injection on each side of the face, guided by a special imaging device, and are followed for 12 weeks. The main goal is to see if the treatment lowers the frequency of moderate-to-severe headache days compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin type A (Botox) injected near the sphenopalatine ganglion
What this could lead to
If effective, this could offer a new add-on treatment option for people with chronic migraine who haven't responded to other therapies, potentially reducing the number of severe headache days.
What could go wrong
This is a phase 3 trial, but results are not yet known. The effect may be modest, and there is a risk of side effects from the injection procedure. Success in this trial does not guarantee long-term benefit or approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

170 people

The number who actually took part.

Started

Oct 2019

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The participants must meet all of the inclusion criteria to participate in this study: 1. Informed and written consent. 2. Male or female, between 18 and 70 years of age 3. Masters a Scandinavian language at level sufficient to fully understand the written and verbal study information 4. Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria 1.3. for chronic migraine at time of inclusion 5. Chronic migraine at least for a period of 1 year prior to inclusion 6. Debut of episodic migraine before the age of 50, and chronic migraine before the age of 65. 7. The condition is pharmacologically refractory as defined in this study as insufficient treatment effect, contraindication(s) or intolerable side effect(s) of at least 3 medications from at least 2 of the following medication (drug) classes 1. Beta-blockers 2. RA(A)S-inhibitors 3. Calcium-antagonists 4. Antiepileptic drugs 5. Tricyclic antidepressants 6. Botulinum toxin A 7. CGRP antagonists 8. Subject has had no change in type, dosage or dose frequency of preventive headache medications \< 3 months prior to baseline/screening, or a minimum of 5 half-lives, whichever is longer. 9. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period. 10. In the case of women of childbearing potential (WOCBP) they have to commit to highly effective contraception in a period of 4 weeks after injection (for details, confer section 4.3) 11. Ability to understand study procedures and to comply with them for the entire length of the study Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline or visit 2 will be excluded from study participation: 1. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances. 2. Subject is unable to differentiate migraine from other concomitant headaches. 3. Subject with secondary headache conditions, with the exception of medication overuse headache. 4. Non-responder in regular clinical practice to preventive medications from ≥6 of the following 7 drug classes: 1. Beta-blockers 2. RA(A)S-inhibitors 3. Calcium-antagonists 4. Antiepileptic drugs 5. Tricyclic antidepressants 6. Botulinum toxin A 7. CGRP antagonists 5. Subject has had a change in type, dosage or dose frequency of preventive headache medications \< 3 months prior to baseline/screening, or a minimum of 5 half-lives, whichever is longer. 6. Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period, eg. prior to IMP administration 7. Botulinum toxin injections in the head and neck region, as part of migraine treatment or otherwise indicated on medical or cosmetic grounds, in the last 4 months before inclusion. 8. The discontinuation of CGRP-antagonists within 3 months before study inclusion or 5 half-lives, whichever is longer, 9. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study inclusion or 5 half-lives, whichever is longer. 10. Subject is currently participating or has participated in the last 3 months in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device. 11. Subject has had previous radiofrequency ablation, balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the trigeminal ganglion or any branch of the trigeminal nerve. 12. Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the SPG. 13. Subject has had blocks of short-acting anaesthetics of the SPG in the last 3 months. 14. Subject is or has been treated with occipital nerve stimulation or deep brain stimulation. 15. Ongoing abuse of drugs (including narcotics) or alcohol. 16. More than 4 days of opioid use per month (including codeine and tramadol), and any use of barbiturates 17. Treatment with pharmacological substances prior to SPG-injection that may interact with BTA (aminoglycosides, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing (tubocurarine derivates), and anticholinesterases). 18. Inadequate contraceptive use. Women of childbearing potential (WOCBP) who do not use highly effective contraception (HEC) or use other medication that may interact and/or otherwise reduce the efficacy of the contraceptive agents in use. 19. Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary at the planned injection site that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure. 20. Facial anomaly or trauma which renders the procedure difficult. 21. Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms. 22. Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months. 23. Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator 24. Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator 25. Patients with disorders that severely inhibits lacrimation, at the discretion of the investigator 26. Patients with previous ischemic cardiovascular and cerebrovascular disorder with, in the opinion of the investigator, a moderate to high risk of new ischemic episodes. 27. Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection. 28. Subject has a history of bleeding disorders or coagulopathy, that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure. 29. Unable to stop antithrombotic medication e.g. platelet aggregation inhibitors and/or anticoagulation therapy, prior to procedure. 30. The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons: * mentally or legally incapacitated or unable to give consent for any reason * in custody due to an administrative or a legal decision, under tutelage, or being admitted to a sanatorium or social institution * has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study 31. The patient is a study centre employee who is directly involved in the study or the relative of such an employee.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Haukeland University Hospital, department of Neurology

    Bergen, Norway

  • Nevroklinikken Universitetet i Oslo, Oslo Universitetssykehus HF

    Oslo, Norway

  • Nordland Hospital, department of Neurology

    Bodø, Norway

  • St Olavs Hospital, Trondheim University Hospital

    Trondheim, Norway

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