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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03066635
First received: February 13, 2017
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Cluster Headache Drug: Botulinum Toxin Type A 25 IU Drug: Botulinum Toxin Type A 12.5 IU Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of cluster headache attacks per week [ Time Frame: for the follow-up period of 6 months ]
    Number of cluster headache attacks per week

  • Duration of cluster headache attacks [ Time Frame: for the follow-up period of 6 months ]
    Duration of cluster headache attacks

  • Days without cluster headache attacks [ Time Frame: for the follow-up period of 6 months ]
    number of days without cluster headache attacks

  • 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

  • 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

  • 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

  • Functional level [ Time Frame: for the follow-up period of 6 months ]
    The functional level will be assessed by the WHO Performance Status

  • 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

  • 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

  • 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

  • disability [ Time Frame: for the follow-up period of 6 months ]
    as assessed by a qualitative questionnaire (HIT-6)

  • Occurrence of autonomic symptoms [ Time Frame: for the follow-up period of 6 months ]
    assessed on Cranial Autonomic Parasympathetic Symptoms (CAPS) scale


Estimated Enrollment: 10
Actual Study Start Date: April 18, 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin 25 IU
5 patients will be injected with 25 IU of Botulinum Toxin Type A towards the otic ganglion in the symptomatic side (ipsilateral to the pain)
Drug: Botulinum Toxin Type A 25 IU
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
Experimental: Botulinum Toxin 12.5 IU
5 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)
Drug: Botulinum Toxin Type A 12.5 IU
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03066635

Contacts
Contact: Joan Crespi, MD 0047 94426880 joan.crespi@ntnu.no
Contact: Daniel F Bratbak, MD daniel.f.bratbak@ntnu.no

Locations
Norway
Department of Neuroscience, Norwegian University of Science and Technology Recruiting
Trondheim, Norway
Contact: Erling A Tronvik, PhD, MD       erling.tronvik@ntnu.no   
Contact: Daniel F Bratbak, MD       daniel.f.bratbak@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Lars Jacob Stovner, prof MD Norwegian University of Science and Technology
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03066635     History of Changes
Other Study ID Numbers: OTOBLOCKCH2016
2016-004213-28 ( EudraCT Number )
Study First Received: February 13, 2017
Last Updated: April 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Nerve block
Ganglia, Parasympathetic
Botulinum Toxins, Type A
Injection

Additional relevant MeSH terms:
Headache
Ganglion Cysts
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 19, 2017