Primary ObjectiveTo provide a definitive answer regarding the efficacy of GON-injection as first-line prophylactic therapy in episodic cluster headache, by showing that GON-injection decreases the mean total dose of verapamil needed during the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hoofdpijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is total dose of verapamil used during the
study period
Secondary outcome
Secondary study parameters
- Median number of days to remission (7 consecutive days without attack)
- Mean number of attacks per day during the study period
- Peak dose verapamil
- Premature termination of study due to need for prophylactic escape medication
Tertiary study parameters
- The total use of attack medication. (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. (For the total
study period and each of the three consecutive 4-week time periods)
- Percentage of patients that are attack-free at days 7, 14 and 28
- Occurrence of *non-cluster* headache (number of days and mean intensity per
affected day; For the total study period and each of the three consecutive
4-week time periods)
- Adverse events
- Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS)
- Satisfaction score (7 point scale, higher scores are better)
Additional endpoints at days 2 and 28, and at the end of the 12-week study
period:
- Would the patient recommend this treatment to others?
- What treatment does the patient think he/she received
(placebo/GON/uncertain)?
- What treatment do the investigators think the patient has had?
Background 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. We
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.
Study objective
Primary Objective
To provide a definitive answer regarding the efficacy of GON-injection as
first-line prophylactic therapy in episodic cluster headache, by showing that
GON-injection decreases the mean total dose of verapamil needed during the
treatment of a cluster episode in episodic cluster headache.
Secondary/Tertiary Objectives:
- To Show that the addition of GON-injection leads to
o Faster attack-freedom (7 consecutive days without attacks) than the current
standard treatment with verapamil only.
o Less side-effects than the current standard treatment with only verapamil.
o A decrease in attack frequency, severity and duration of attacks (and thus a
decrease in the use of attack medication) compared to the current standard
treatment with verapamil only.
- To learn how long the beneficial effects of GON-injection will last.
- To show that GON-injection will lead to higher patient satisfaction scores,
compared to the current standard treatment with only verapamil.
Study design
Multicentre, randomized, double-blind placebo-controlled study with 12 weeks
follow-up.
Intervention
In addition to the standard treatment with oral verapamil (start 120 mg
extended release and increased if necessary according to current clinical
practice), patients will be allocated to one of 2 study-treatments:
[I] Occipital placebo saline injection (n=40)
[II] GON-injection (n=40)
Study burden and risks
In this study, there is no great (extra) burden end there are no significant
risks expected. Patients will start regular treatment for a cluster headache
episode (verapamil, according to the current clinical standard); and in
addition to this they will either receive a GON injection with steroids or a
placebo injection with saline. We expect only minor, local side effects from
both types of injection.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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 years or older
- 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-002224-17-NL |
| CCMO | NL67197.058.18 |