GON-injection for a Sooner and Better Treatment of Cluster Headache (CHIANTI)
Primary Purpose
Cluster Headache, Episodic, Greater Occipital Nerve Injection
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache, Episodic
Eligibility 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
Sites / Locations
- Boerhaave Clinics
- LUMCRecruiting
- Alrijne Ziekenhuis
- Tergooi Ziekenhuis
- Zuyderland Medisch Centrum
- Canisius-Wilhelmina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Verum
Arm Description
Injection of NaCl
Outcomes
Primary Outcome Measures
Verapamil mean total dose
Difference in mean total dose of verapamil used during the study period
Secondary Outcome Measures
Days to remission
Median number of days to remission (7 consecutive days without attack)
Daily attacks
Mean number of attacks per day during the study period
Peak dose verapamil
Peak dose verapamil
Preamature termination
Premature termination of study due to need for escape medication
Full Information
NCT ID
NCT04014634
First Posted
July 8, 2019
Last Updated
October 8, 2019
Sponsor
Leiden University Medical Center
Collaborators
Netherlands Brain Foundation, Innovatiefonds Zorgverzekeraars
1. Study Identification
Unique Protocol Identification Number
NCT04014634
Brief Title
GON-injection for a Sooner and Better Treatment of Cluster Headache
Acronym
CHIANTI
Official Title
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Netherlands Brain Foundation, Innovatiefonds Zorgverzekeraars
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache, Episodic, Greater Occipital Nerve Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injection of NaCl
Arm Title
Verum
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Single GON injection with methylprednisolone
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single GON-injection with NaCl
Primary Outcome Measure Information:
Title
Verapamil mean total dose
Description
Difference in mean total dose of verapamil used during the study period
Time Frame
12 week period
Secondary Outcome Measure Information:
Title
Days to remission
Description
Median number of days to remission (7 consecutive days without attack)
Time Frame
12 weeks
Title
Daily attacks
Description
Mean number of attacks per day during the study period
Time Frame
12 weeks
Title
Peak dose verapamil
Description
Peak dose verapamil
Time Frame
12 weeks
Title
Preamature termination
Description
Premature termination of study due to need for escape medication
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Use of attack medication
Description
The total use of attack medication (stratified for oxygen and sumatriptan)
Time Frame
12 weeks
Title
Daily attack severity and duration
Description
Mean number, severity (1-10) and duration of attack per day.
Time Frame
For the total study period and each of the three consecutive 4-week time periods
Title
Attack-freedom
Description
Percentage of patients that are attack-free at days 7, 14 and 28
Time Frame
days 7, 14 and 28
Title
Non-cluster headache
Description
Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)
Time Frame
12 weeks
Title
Adverse events
Description
Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))
Time Frame
12 weeks
Title
Subjective feeling
Description
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)
Time Frame
Days 7, 14 and 28
Title
Satisfaction score
Description
Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)
Time Frame
12 weeks
Title
Recommendation
Description
Would the patient recommend this treatment to others
Time Frame
Days 7, 14 and 28
Title
Blinding participants
Description
What treatment does the patient think he/she received (placebo/GON/uncertain)
Time Frame
Days 7, 14 and 28
Title
Blinding investigators
Description
What treatment do the investigators think the patient has had
Time Frame
Days 7, 14 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roemer Brandt, MD
Phone
0031620063703
Email
r.b.brandt@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Rolf Fronczek, MD, PhD
Email
r.fronczek@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Fronczek, MD, PhD
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boerhaave Clinics
City
Amsterdam
State/Province
Noord Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emile Couturier, MD, PhD
Facility Name
LUMC
City
Leiden
State/Province
Zuid Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roemer Brandt, MD
Phone
0031620063703
Email
r.b.brandt@lumc.nl
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
State/Province
Zuid Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Haan, MD, PhD
Facility Name
Tergooi Ziekenhuis
City
Blaricum
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Carpay, MD, PhD
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Gerlach, MD, PhD
Facility Name
Canisius-Wilhelmina Hospital
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Mulleners, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
GON-injection for a Sooner and Better Treatment of Cluster Headache
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