This study has been transitioned to CTIS with ID 2024-514311-10-00 check the CTIS register for the current data. The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more months…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: Retention rate (= time between the first injection and
end-of-treatment; survival curves verum vs. placebo)
Secondary outcome
Secondary outcome measures (verum vs. placebo):
- Frequency of daily cluster headache attacks
- The use of acute attack medication per day (subcutaneous sumatriptan and 100%
oxygen)
- Mean duration and severity (1-10) of attacks
- Injection interval
- Total number of injections in study period
- Proportion of participants still in study at 1 year
- Participants idea: did they receive placebo or verum?
- Physician*s idea: did they administer placebo or verum?
- Adverse events + ultrasound structural integrity measurements greater
occipital nerve
- Proportion of subjects with a >50% and 100% reduction in attack frequency
- Daily quality of life (EQ 5D)
- Healthcare use & productivity losses
Background summary
A single injection of the greater occipital nerve (GON) with corticosteroids
(*GON-injection*) has been shown to be efficacious for the prophylactic
treatment of cluster headache, with only mild, local side effects and often has
its effect within days. It is a low-cost and safe treatment option; however,
the beneficial effects are limited to weeks to months. This makes the injection
suitable for episodic cluster headache, where periods with headache attacks
last weeks to months. However, the effect of repeated GON-injections has never
been studied in a double-blind randomized trial as a prophylactic therapy in a
well-documented group of chronic patients. As such, (repeated) GON-injection
has not yet found its place in current (inter)national treatment protocols for
chronic cluster headache. The injection is often only used as a last-resort
treatment in a very limited number of headache centres in a trial-and-error
approach with a treatment interval varying between 3 and 6 months. It is,
therefore, not known what chronic cluster headache patients can expect from
this treatment.
Study objective
This study has been transitioned to CTIS with ID 2024-514311-10-00 check the CTIS register for the current data.
The primary objective is to determine if repeated GON-injection result in
effective control of cluster headache attacks for more months compared to
placebo in chronic cluster headache.
Secondary objectives are to determine:
- If the effect of one GON-injection predict the effects of subsequent
GON-injections.
- The median GON-injection interval.
- The tolerability of repeated GON-injections .
- Structural integrity of the GON after the study period.
Study design
Bi-centre, randomized, double-blind, placebo-controlled retention trial with a
maximum follow-up of one year.
Intervention
The verum group will receive a GON-injection with 80mg methylprednisolone
suspension. The placebo group will receive 2 ml of saline. Efficacy will be
assessed with weekly attack journals and structural integrity of the GON will
be assessed with ultrasound imaging.
Study burden and risks
When effective, repeated GON-injections will decrease the need for high doses
of prophylactic treatment with its associated high risk of side effects in
chronic cluster headache patients. The burden is relatively low, since follow
up will include non-invasive ultrasounds of the GON, and GON-injections,
according to the study protocol. Furthermore, a weekly attack journal and
three, monthly, online questionnaires will be administered. No serious side
effects were reported in previous studies regarding (repeated) greater
occipital nerve injection, with only minor (local) side effects. In conclusion,
we feel that the risks are very small since GON-injection is already proven
safe in previous studies.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Age >=18
- Chronic cluster headache (International Classification of Headache Disorders
- third edition; ICHD-3)
- Ictal pain must be always at the same side
- >=4 weekly attacks of cluster headache in the prospective one-month baseline
observation period
- On a stable regimen of cluster headache prophylactics for >4 weeks prior to
onset of study treatment and agreeing not to increase the dose and not starting
a new cluster prophylactic during the study period
Exclusion criteria
- Contra-indication against, or current use of, corticosteroids
- Occipital nerve stimulation (ONS)
- Use of anticoagulation medication or a known bleeding disorder
- Inability to use an electronic diary to monitor individual attacks and other
items
- Other headaches if the patient cannot reliably distinguish them from attacks
of cluster headache
- Current use of prophylactic medication for other headaches
- Pregnancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EU-CTR | CTIS2024-514311-10-00 |
| EudraCT | EUCTR2021-006687-25-NL |
| CCMO | NL79665.058.22 |