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GON-injection for a Sooner and Better Treatment of Cluster Headache (CHIANTI)

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ClinicalTrials.gov Identifier: NCT04014634
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Hersenstichting
Innovatiefonds Zorgverzekeraars
Information provided by (Responsible Party):
RolfFronczek, Leiden University Medical Center

Brief Summary:
Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.

Condition or disease Intervention/treatment Phase
Cluster Headache, Episodic Greater Occipital Nerve Injection Drug: Methylprednisolone Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Placebo Comparator: Placebo
Injection of NaCl
Other: Placebo
Single GON-injection with NaCl

Experimental: Verum Drug: Methylprednisolone
Single GON injection with methylprednisolone




Primary Outcome Measures :
  1. Verapamil mean total dose [ Time Frame: 12 week period ]
    Difference in mean total dose of verapamil used during the study period


Secondary Outcome Measures :
  1. Days to remission [ Time Frame: 12 weeks ]
    Median number of days to remission (7 consecutive days without attack)

  2. Daily attacks [ Time Frame: 12 weeks ]
    Mean number of attacks per day during the study period

  3. Peak dose verapamil [ Time Frame: 12 weeks ]
    Peak dose verapamil

  4. Preamature termination [ Time Frame: 12 weeks ]
    Premature termination of study due to need for escape medication


Other Outcome Measures:
  1. Use of attack medication [ Time Frame: 12 weeks ]
    The total use of attack medication (stratified for oxygen and sumatriptan)

  2. Daily attack severity and duration [ Time Frame: For the total study period and each of the three consecutive 4-week time periods ]
    Mean number, severity (1-10) and duration of attack per day.

  3. Attack-freedom [ Time Frame: days 7, 14 and 28 ]
    Percentage of patients that are attack-free at days 7, 14 and 28

  4. Non-cluster headache [ Time Frame: 12 weeks ]
    Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)

  5. Adverse events [ Time Frame: 12 weeks ]
    Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))

  6. Subjective feeling [ Time Frame: Days 7, 14 and 28 ]
    Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS. Scale from 0 to 10 where 0 is worst imaginable and 10 best imaginable)

  7. Satisfaction score [ Time Frame: 12 weeks ]
    Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)

  8. Recommendation [ Time Frame: Days 7, 14 and 28 ]
    Would the patient recommend this treatment to others

  9. Blinding participants [ Time Frame: Days 7, 14 and 28 ]
    What treatment does the patient think he/she received (placebo/GON/uncertain)

  10. Blinding investigators [ Time Frame: Days 7, 14 and 28 ]
    What treatment do the investigators think the patient has had



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
  • Patients have to be aged 18-65 years
  • Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
  • Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
  • Patients should be in their cluster period for shorter than 4 weeks before inclusion.

Exclusion Criteria:

  • A contraindication for treatment with steroids or verapamil
  • The use of anticoagulants or known bleeding disorder.
  • Use of any prophylactic medication for cluster headache
  • Patients with a history of other primary headache who are currently using prophylactic medication for this headache
  • Pregnancy

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): NCT04014634


Contacts
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Contact: Roemer Brandt, MD 0031620063703 r.b.brandt@lumc.nl
Contact: Rolf Fronczek, MD, PhD r.fronczek@lumc.nl

Locations
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Netherlands
Boerhaave Clinics Not yet recruiting
Amsterdam, Noord Holland, Netherlands
Contact: Emile Couturier, MD, PhD         
LUMC Recruiting
Leiden, Zuid Holland, Netherlands
Contact: Roemer Brandt, MD    0031620063703    r.b.brandt@lumc.nl   
Alrijne Ziekenhuis Not yet recruiting
Leiderdorp, Zuid Holland, Netherlands
Contact: Joost Haan, MD, PhD         
Tergooi Ziekenhuis Not yet recruiting
Blaricum, Netherlands
Contact: Hans Carpay, MD, PhD         
Zuyderland Medisch Centrum Not yet recruiting
Heerlen, Netherlands
Contact: Olivier Gerlach, MD, PhD         
Canisius-Wilhelmina Hospital Not yet recruiting
Nijmegen, Netherlands
Contact: Wim Mulleners, MD, PhD         
Sponsors and Collaborators
Leiden University Medical Center
Hersenstichting
Innovatiefonds Zorgverzekeraars
Investigators
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Principal Investigator: Rolf Fronczek, MD, PhD LUMC
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Responsible Party: RolfFronczek, Principal investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04014634    
Other Study ID Numbers: NL6719705818
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All Data will be stored using Castor EDC. All hard copies will be stored in the individual centers. If requested, after study completion, data can be shared with de PIs in participating centers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents