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Cluster HeadachePhase 1/2NCT03066635

Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues

A Phase 1/2 study testing Botulinum Toxin Type A 25 IU and Botulinum Toxin Type A 12.5 IU in people with Cluster Headache, 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

Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of the most severe pains known to man, having a large impact on the sufferer's quality of life. A parasympathetic dysfunction in CH has been suggested. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cluster Headache
What is being tested?
Botulinum Toxin Type A 25 IU and Botulinum Toxin Type A 12.5 IU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNorway
Study dates
18 Apr 2017to 13 Sep 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed and written consent
  • Fulfilling International Classification of Headache Disorders (ICHD) -3 Beta criteria for chronic cluster headache
  • Mean attack frequency of four attacks per week or more
  • Agreeing to refrain from starting new prophylactic cluster headache medication, including steroids, or any other therapy aimed at cluster headache, and agreeing to maintain existing prophylactic cluster headache medication from 4 weeks before entering the baseline period throughout the duration of the study
  • Intractable cluster headache, i.e. unsatisfactory effect, intolerable side effects or contraindication of at least 2 of the following medications: Verapamil, Lithium, Suboccipital steroid injection,
  • Able to distinguish between cluster headache attacks and other types of headache.

Who cannot join

  • Modification or addition of any prophylactic drug dose used against cluster headache in the last 4 weeks before inclusion of during the trial
  • Use of antipsychotic medication in the last 4 weeks before inclusion
  • Concomitant significant heart or lung disease
  • Systemic or local conditions which can increase the risk of the procedure
  • Psychiatric or psychological conditions interfering with the participation in the study
  • Pregnancy
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  • Breast feeding
  • Inadequate use of contraceptives
  • Opioid overuse
  • Abuse of drugs including alcohol
  • Anatomical variants which might impede the study treatment
  • Known hypersensitivity to botulinum toxin type A or any of the excipients found in Botox
  • Current treatment with drugs that interact with botulinum toxin: aminoglycosides, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing agents (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinesterases.
  • Previous cerebral ischemic infarction
  • Not able to take magnetic resonance imaging (MRI)
  • Previous destructive surgery of interventional procedures involving the C2 and C3 roots (vertebrae), sphenopalatine ganglion, any extracranial nerve, trigeminal nerve, or deep brain stimulation.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Department of Neuroscience, Norwegian University of Science and Technology

    Trondheim

Other trials in Norway

About this study

Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of the most severe pains known to man, having a large impact on the sufferer's quality of life. A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been a target for treatment of primary headache disorders for more than a century but there are several anatomic and physiologic studies that suggest that another cranial parasympathetic ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster headache. Recruitment of patients will be solely in Norway. There is no data available to determine the correct dosage of botulinum toxin. A similar neural structure that has been blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU. Even though the number of treated patients is low, there did not appear to be differences in the adverse events profile between those who received 25 Iu and those who received 50 IU. The investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25 IU of botulinum toxin.

Being tested
Botulinum Toxin Type A 25 IU, Botulinum Toxin Type A 12.5 IU
Keywords
Nerve block, Ganglia, Parasympathetic, Botulinum Toxins, Type A, Injection
Medical subject headings
Cluster Headache, Ganglion Cysts

What participants receive

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

  • Botulinum Toxin Type A 25 IUDrug

    Also called Botox, BTA, Allergan

    injection with 25 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device

  • Botulinum Toxin Type A 12.5 IUDrug

    Also called Botox, BTA, Allergan

    injection with 12.5 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device

Study groups in NCT03066635
Study groupRoleWhat they receive
Botulinum Toxin 25 IUExperimental5 patients will be injected with 25 IU of Botulinum Toxin Type A towards the otic ganglion in the symptomatic side (ipsilateral to the pain)
Receives: Drug: Botulinum Toxin Type A 25 IU
Botulinum Toxin 12.5 IUExperimental5 patients will be injected with 12.5 IU of Botulinum Toxin Type A towards the otic ganglion in the symptomatic side (ipsilateral to the pain)
Receives: Drug: Botulinum Toxin Type A 12.5 IU

What is being measured

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

  1. Number of adverse events (AE)

    All adverse events will be registered. The likelihood of a relationship between the AE and the pharmacological substance or the procedure will be evaluated. Data will be collected from the headache diary (free text) and open questions at the office follow up visits.

    Measured: for the follow-up period of 6 months

Secondary outcomes (12)

  1. Number of cluster headache attacks per week

    Number of cluster headache attacks per week

    Measured: for the follow-up period of 6 months

  2. Duration of cluster headache attacks

    Duration of cluster headache attacks

    Measured: for the follow-up period of 6 months

  3. Days without cluster headache attacks

    number of days without cluster headache attacks

    Measured: for the follow-up period of 6 months

  4. Headache intensity on a 0-5 scale

    The headache intensity is registered in the headache diary using a scale from 0-5

    Measured: for the follow-up period of 6 months

  5. Mean intensity per attack

    The headache intensity is registered in the headache diary using a scale from 0-5

    Measured: for the follow-up period of 6 months

  6. Mean number of attacks with intensity grade 4-5

    Mean number of attacks with intensity grade 4-5

    Measured: for the follow-up period of 6 months

  7. Functional level

    The functional level will be assessed by the WHO Performance Status

    Measured: for the follow-up period of 6 months

  8. Triptan use per 4 weeks

    Triptan use per 4 weeks during the whole duration of the study

    Measured: for the follow-up period of 6 months

  9. Number of analgesic doses per 4 weeks

    the number of analgesic doses per 4 weeks during the whole duration of the study

    Measured: for the follow-up period of 6 months

  10. Absenteeism due to cluster headache

    Absenteeism due to cluster headache as assessed by the headache diary

    Measured: for the follow-up period of 6 months

  11. disability

    as assessed by a qualitative questionnaire (HIT-6)

    Measured: for the follow-up period of 6 months

  12. Occurrence of autonomic symptoms

    assessed on Cranial Autonomic Parasympathetic Symptoms (CAPS) scale

    Measured: for the follow-up period of 6 months

Timeline

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

  1. First posted28 Feb 2017
  2. Study start18 Apr 2017
  3. Primary completion13 Sep 2019
  4. Study completion13 Sep 2019

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066635
Sponsor's protocol ID
OTOBLOCKCH2016
Other IDs
2016-004213-28, 2016
Status last verified
Jun 2021
First submitted
13 Feb 2017
Last updated
23 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Crespi J, Bratbak D, Dodick DW, Matharu M, Solheim O, Gulati S, Berntsen EM, Tronvik E. Open-Label, Multi-Dose, Pilot Safety Study of Injection of OnabotulinumtoxinA Toward the Otic Ganglion for the Treatment of Intractable Chronic Cluster Headache. Headache. 2020 Sep;60(8):1632-1643. doi: 10.1111/head.13889. Epub 2020 Jun 25.

    PubMed 32583902

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Botulinum Toxin Type A 25 IU and Botulinum Toxin Type A 12.5 IU in people with Cluster Headache, 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 6 inclusion and 16 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 23 Jun 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (AE) (time frame: for the follow-up period of 6 months). 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 NCT03066635, 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 23 Jun 2021.

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