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NCT Number: NCT03066635

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

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.

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Connective Tissue Diseases Cysts Ganglion Cysts Headache Disorders Headache Disorders, Primary Mucinoses Neoplasms Nervous System Diseases Skin and Connective Tissue Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Botulinum Toxin Type A 25 IU

Drug

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

Other names: Botox, BTA, Allergan

Botulinum Toxin Type A 12.5 IU

Drug

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

Other names: Botox, BTA, Allergan

Primary outcomes

  1. Number of adverse events (AE)

    Time frame: for the follow-up period of 6 months

    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.

Secondary outcomes

  1. Number of cluster headache attacks per week

    Time frame: for the follow-up period of 6 months

    Number of cluster headache attacks per week

  2. Duration of cluster headache attacks

    Time frame: for the follow-up period of 6 months

    Duration of cluster headache attacks

  3. Days without cluster headache attacks

    Time frame: for the follow-up period of 6 months

    number of days without cluster headache attacks

  4. Headache intensity on a 0-5 scale

    Time frame: for the follow-up period of 6 months

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

  5. Mean intensity per attack

    Time frame: for the follow-up period of 6 months

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

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

    Time frame: for the follow-up period of 6 months

    Mean number of attacks with intensity grade 4-5

  7. Functional level

    Time frame: for the follow-up period of 6 months

    The functional level will be assessed by the WHO Performance Status

  8. Triptan use per 4 weeks

    Time frame: for the follow-up period of 6 months

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

  9. Number of analgesic doses per 4 weeks

    Time frame: for the follow-up period of 6 months

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

  10. Absenteeism due to cluster headache

    Time frame: for the follow-up period of 6 months

    Absenteeism due to cluster headache as assessed by the headache diary

  11. disability

    Time frame: for the follow-up period of 6 months

    as assessed by a qualitative questionnaire (HIT-6)

  12. Occurrence of autonomic symptoms

    Time frame: for the follow-up period of 6 months

    assessed on Cranial Autonomic Parasympathetic Symptoms (CAPS) scale

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2017
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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