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Trial record 34 of 243 for:    Recruiting, Not yet recruiting, Available Studies | Headache

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache (BASIC)

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ClinicalTrials.gov Identifier: NCT03944876
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
University College, London
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Catholic University of Valencia
University Hospital, Essen
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Botulinum toxin type A Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Headache

Arm Intervention/treatment
Experimental: Botox injections towards SPG
Botulinum Toxin type A injections
Drug: Botulinum toxin type A
Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)
Other Name: botox

Placebo Comparator: Controls
placebo injections
Drug: placebo
0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5-8 post-intervention in the treatment group versus the placebo group [ Time Frame: week 5 through week 8 in the post-injection period ]
    Change from baseline to weeks 5-8 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary.


Secondary Outcome Measures :
  1. Difference in occurrence of adverse events (AEs) and serious adverse events (SAEs) in the active group versus the placebo group [ Time Frame: week 1 through week 12 in the post-injection period ]
    All adverse events and serious adverse events occurring in the 3 months follow up are registered in an electronic case report form (CRF). Frequency of AE and SAE are compared between the placebo group and the treatment group

  2. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group [ Time Frame: week 9 through week 12 in the post-injection period ]
    Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary

  3. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5-8 post-intervention in the active group versus the placebo group, in the prespecified subgroups [ Time Frame: week 5 through week 8 in the post-injection period ]
    Change from baseline to weeks 5 - 8 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and low versus high attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

  4. Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, in the prespecified subgroups [ Time Frame: week 9 through week 12 in the post-injection period ]
    Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and high versus low attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

  5. Difference in the number of therapeutic responders in the active group versus the placebo group. [ Time Frame: week 5 through week 8 in the post-injection period ]
    Number of therapeutic responders as defined as a ≥ 30% reduction in attack frequency, intensity or both during weeks 5 - 8 post-intervention compared to baseline week 5-8. The number in the placebo and intervention group are compared

  6. Difference in the number of attack frequency responders [ Time Frame: week 5 through week 8 in the post-injection period ]
    Number of attack frequency responders as defined as a ≥ 30% reduction in attack frequency during weeks 5-8 post-intervention compared to baseline. The number in the placebo and intervention group are compared

  7. Difference in change from baseline week 5-8 in mean attack intensity week 5 - 8 post-intervention in the active group versus the placebo group. [ Time Frame: week 5 through week 8 in the post-injection period ]
    Mean attack intensity (10-point numerical response scale - NRS) week 5-8 post intervention compared to baseline in the intervention group versus the placebo group.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed and written consent.
  2. Male or female, 18-85 years of age
  3. Headache attacks fulfilling the International Classification of Headache Disorders (ICHD) III criteria for chronic cluster headache (CCH) 3.1.2.
  4. Dominant headache laterality with ≥ 80% of cluster headache attacks on one side.
  5. Subject reports ≥ 8 cluster attacks/week on the side of their dominant headache laterality in the 3 months prior to inclusion and in the baseline period.
  6. The condition is pharmacologically refractory defined as suboptimal effect or intolerable side effects or contraindication for verapamil or lithium or suboccipital steroid injection.
  7. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period.
  8. Subject is able to differentiate concomitant headaches from cluster headache.
  9. In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception in a period of 4 weeks after injection.
  10. Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

  1. Subject has had a change in type, dosage or dose frequency of preventive headache medications < 1 months prior to baseline/screening or 5 half-lives, whichever is longer.1
  2. Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period, eg. prior to IMP administration.
  3. Non-responder to both oxygen and triptan.
  4. Non-responder in regular clinical practice at the discretion of the investigator to ≥4 of the listed preventive medications

    1. Verapamil
    2. Lithium
    3. Topiramate
    4. Valproate
    5. Greater occipital nerve (GON) block
    6. CGRP-antagonist
  5. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer.
  6. 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.
  7. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances.
  8. Abuse of drugs or alcohol.
  9. Use of opioids for ≥10 days per month.
  10. Treatment with pharmacological substances that may interact with BTA (aminoglycosides, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinesterases.).
  11. WOCBP that do not adhere to the requirements for HEC, as noted in inclusion criteria 9 and outlined in section 3.3.
  12. Pregnancy or breastfeeding in the study period
  13. Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned injection site that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure.
  14. Facial anomaly or trauma which renders the procedure difficult.2
  15. Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms.
  16. 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.
  17. 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.
  18. Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator.
  19. Patient with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.
  20. Patient with disorders that are known contraindication for Botox® treatment, especially neuromuscular disorders such as motorneuron disorders and myasthenic syndromes
  21. Subject has had previous radiofrequency ablation, balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the ipsilateral trigeminal ganglion or any branch of the trigeminal nerve.
  22. Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the ipsilateral SPG.
  23. Subject is currently or has been previously treated with occipital nerve stimulation or deep brain stimulation.
  24. Subject has had blocks of short-acting anaesthetics of the ipsilateral SPG in the last 3 months.
  25. Subject has undergone onabotulinumtoxinA injections of the head and/or neck or has had an occipital nerve block in the last 3 months.
  26. Subject is anticipated to require any excluded medication, device, or procedure during the study.
  27. Subject has a history of bleeding disorders and in the opinion of the Investigator, may lead to an inability to properly conduct the procedure.
  28. Subject has a history of coagulopathy.
  29. Subject is unable to stop antithrombotic medication, eg. anticoagulants and/or antiplatelet therapy, before procedure.
  30. The subject has been diagnosed with another trigeminal autonomic cephalalgia or trigeminal neuralgia.
  31. 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.
  32. The patient is a study centre employee who is directly involved in the study or the relative of such an employee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944876


Contacts
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Contact: Tore Wergeland Meisingset, md phd +47 728 21 335 tore.w.meisingset@ntnu.no
Contact: Erling Tronvik, md phd erling.tronvik@ntnu.no

Locations
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Germany
Universitaetsklinikum Essen Not yet recruiting
Essen, Germany
Contact: Dagny Holle-Lee, md phd    +49 2017232385    Dagny.Holle-Lee@uk-essen.de   
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI) Not yet recruiting
Milano, Italy
Contact: Massimo Leone, md prof    +39 02.23941    Massimo.Leone@istituto-besta.it   
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Erling Tronvik, md phd    +47 40458528    erling.tronvik@ntnu.no   
Spain
Department of Neurology, University Clinic Hospital. Catholic University of Valencia Recruiting
Valencia, Spain
Contact: Miguel Lainez, md prof    +34 963868863    miguel.lainez@sen.es   
United Kingdom
National Hospital of Neurology and Neurosurgery, University College of London Not yet recruiting
London, United Kingdom
Contact: Manjit Matharu, MD phd    +44 7976264746    manjit.matharu@nhs.net   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
University College, London
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Catholic University of Valencia
University Hospital, Essen
Investigators
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Study Director: Geir Bråthen, md phd St. Olavs Hospital

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03944876     History of Changes
Other Study ID Numbers: 2018/1821
2018-003148-21 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication will be shared within 6 months after study results publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after study results publication
Access Criteria: erling.tronvik@ntnu.no

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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:
Botulinum Toxin Type A
Sphenopalatine Ganglion Block
Autonomic Nerve Block
Injections
Additional relevant MeSH terms:
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Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Ganglion Cysts
Pain
Neurologic Manifestations
Signs and Symptoms
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
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