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出境医 / 临床实验 / GON-injection for a Sooner and Better Treatment of Cluster Headache (CHIANTI)

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Contacts
Layout table for location contacts
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
Netherlands Brain Foundation
Innovatiefonds Zorgverzekeraars
Investigators
Layout table for investigator information
Principal Investigator: Rolf Fronczek, MD, PhD LUMC
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019) 		Verapamil mean total dose [ Time Frame: 12 week period ]
Difference in mean total dose of verapamil used during the study period
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Verapamil mean [ Time Frame: 12 week period ]
Difference in mean total dose of verapamil used during the study period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Days to remission [ Time Frame: 12 weeks ]
    Median number of days to remission (7 consecutive days without attack)
  • Daily attacks [ Time Frame: 12 weeks ]
    Mean number of attacks per day during the study period
  • Peak dose verapamil [ Time Frame: 12 weeks ]
    Peak dose verapamil
  • Preamature termination [ Time Frame: 12 weeks ]
    Premature termination of study due to need for escape medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 8, 2019)
  • Use of attack medication [ Time Frame: 12 weeks ]
    The total use of attack medication (stratified for oxygen and sumatriptan)
  • 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.
  • Attack-freedom [ Time Frame: days 7, 14 and 28 ]
    Percentage of patients that are attack-free at days 7, 14 and 28
  • Non-cluster headache [ Time Frame: 12 weeks ]
    Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)
  • Adverse events [ Time Frame: 12 weeks ]
    Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))
  • 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)
  • Satisfaction score [ Time Frame: 12 weeks ]
    Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)
  • Recommendation [ Time Frame: Days 7, 14 and 28 ]
    Would the patient recommend this treatment to others
  • Blinding participants [ Time Frame: Days 7, 14 and 28 ]
    What treatment does the patient think he/she received (placebo/GON/uncertain)
  • Blinding investigators [ Time Frame: Days 7, 14 and 28 ]
    What treatment do the investigators think the patient has had
Original Other Pre-specified Outcome Measures
 (submitted: July 8, 2019)
  • Use of attack medication [ Time Frame: 12 weeks ]
    The total use of attack medication (stratified for oxygen and sumatriptan)
  • 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.
  • Attack-freedom [ Time Frame: days 7, 14 and 28 ]
    Percentage of patients that are attack-free at days 7, 14 and 28
  • Non-cluster headache [ Time Frame: 12 weeks ]
    Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)
  • Adverse events [ Time Frame: 12 weeks ]
    Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))
  • Subjective feeling [ Time Frame: Days 7, 14 and 28 ]
    Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS)
  • Satisfaction [ Time Frame: 12 weeks ]
    Satisfaction score (7 point scale, higher scores are better)
  • Recommendation [ Time Frame: Days 7, 14 and 28 ]
    Would the patient recommend this treatment to others
  • Blinding participants [ Time Frame: Days 7, 14 and 28 ]
    What treatment does the patient think he/she received (placebo/GON/uncertain)
  • Blinding investigators [ Time Frame: Days 7, 14 and 28 ]
    What treatment do the investigators think the patient has had
 
Descriptive Information
Brief Title  ICMJE GON-injection for a Sooner and Better Treatment of Cluster Headache
Official Title  ICMJE GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cluster Headache, Episodic
  • Greater Occipital Nerve Injection
Intervention  ICMJE
  • Drug: Methylprednisolone
    Single GON injection with methylprednisolone
  • Other: Placebo
    Single GON-injection with NaCl
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Injection of NaCl
    Intervention: Other: Placebo
  • Experimental: Verum
    Intervention: Drug: Methylprednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roemer Brandt, MD 0031620063703 r.b.brandt@lumc.nl
Contact: Rolf Fronczek, MD, PhD r.fronczek@lumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014634
Other Study ID Numbers  ICMJE NL6719705818
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party RolfFronczek, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE
  • Netherlands Brain Foundation
  • Innovatiefonds Zorgverzekeraars
Investigators  ICMJE
Principal Investigator: Rolf Fronczek, MD, PhD LUMC
PRS Account Leiden University Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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