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JOURNAL ONKOLOGIE – STUDIE
BASIC

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

Rekrutierend

NCT-Nummer:
NCT03944876

Studienbeginn:
November 2019

Letztes Update:
29.09.2023

Wirkstoff:
Botulinum toxin type A, Placebo

Indikation (Clinical Trials):
Headache, Ganglion Cysts, Cluster Headache

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Norwegian University of Science and Technology

Collaborator:
St. Olavs Hospital, University College, London, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Catholic University of Valencia, Universitätsklinikum Hamburg-Eppendorf,

Studienleiter

Geir Bråthen, md phd
Study Director
St. Olavs Hospital

Kontakt

Studienlocations
(3 von 5)

Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI)
Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Massimo Leone, md prof
Phone: +39 02.23941
E-Mail: Massimo.Leone@istituto-besta.it» Ansprechpartner anzeigen
Department of Neurology, University Clinic Hospital. Catholic University of Valencia
Valencia
SpainRekrutierend» Google-Maps
Ansprechpartner:
Miguel Lainez, md prof
Phone: +34 963868863
E-Mail: miguel.lainez@sen.es» Ansprechpartner anzeigen
National Hospital of Neurology and Neurosurgery, University College of London
London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Manjit Matharu, MD phd
Phone: +44 7976264746
E-Mail: manjit.matharu@nhs.net» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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 .

Ein-/Ausschlusskriterien

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 an average of ≥ 4 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 ≥ two weeks prior to baseline/screening or 5 half-lives, whichever is

longer.

2. Subject currently treated with occipital nerve stimulation, deep brain stimulation or

other implantable device, that have changed parameters in the last month, or are

unable to keep parameters stable throughout the study.

3. Current or previous treatment with implanted medical devices targeting the SPG

4. Subject has had a change in type, dosage or dose frequency of preventive headache

medications during the baseline period, eg. prior to IMP administration.

5. Non-responder to both oxygen and triptan.

6. 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.

7. 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.

8. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline,

any botulinum toxin or similar substances.

9. Abuse of drugs or alcohol.

10. Use of opioids for ≥10 days per month.

11. Treatment with pharmacological substances that may interact with BTA (aminoglycosids,

spectinomycin, neuromuscular blockers, both depolarizing agents (such as

succinylcholine) or non-depolarizing (tubocurarine derivates), lincosamides,

polymyxins, quinidine, magnesium sulfate or anticholinestases.).

12. WOCBP that do not adhere to the requirements for HEC, as noted in inclusion criteria 9

and outlined in section 3.3.

13. Pregnancy or breastfeeding in the study period

14. 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.

15. Facial anomaly or trauma which renders the procedure difficult.2

16. Subject currently has an active oral or dental abscess or a local infection at the

site of injection based on present symptoms.

17. 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.

18. 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.

19. Patients with comorbid psychiatric disorders with psychotic or other symptoms making

compliance with the study protocol difficult, at the discretion of the investigator.

20. 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.

21. Patient with disorders that are known contraindication for Botox® treatment,

especially neuromuscular disorders such as motorneuron disorders and myasthenic

syndromes

22. 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.

23. 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.

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 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.

Studien-Rationale

Primary outcome:

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:

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.

Studien-Arme

  • Experimental: Botox injections towards SPG
    Botulinum Toxin type A injections
  • Placebo Comparator: Controls
    placebo injections

Geprüfte Regime

  • Botulinum toxin type A (botox):
    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)
  • placebo (Sodium Chloride):
    0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

Quelle: ClinicalTrials.gov


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