A Phase 4 interventional study of Methylprednisolone and Placebo in Cluster Headache, Episodic and Greater Occipital Nerve Injection, sponsored by Leiden University Medical Center. Completed at 6 sites in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Leiden University Medical Center · Phase 4, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 70 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection of NaCl
Other: Placebo
Drug: Methylprednisolone
Single GON injection with methylprednisolone
Single GON-injection with NaCl
Verapamil mean total dose
Difference in mean total dose of verapamil used during the study period
Time frame: 12 week period
Days to remission
Median number of days to remission (7 consecutive days without attack)
Time frame: 12 weeks
Daily attacks
Mean number of attacks per day during the study period
Time frame: 12 weeks
Peak dose verapamil
Peak dose verapamil
Time frame: 12 weeks
Preamature termination
Premature termination of study due to need for escape medication
Time frame: 12 weeks
Use of attack medication
The total use of attack medication (stratified for oxygen and sumatriptan)
Time frame: 12 weeks
Daily attack severity and duration
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
Attack-freedom
Percentage of patients that are attack-free at days 7, 14 and 28
Time frame: days 7, 14 and 28
Non-cluster headache
Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)
Time frame: 12 weeks
Adverse events
Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))
Time frame: 12 weeks
Subjective feeling
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
Satisfaction score
Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)
Time frame: 12 weeks
Recommendation
Would the patient recommend this treatment to others
Time frame: Days 7, 14 and 28
Blinding participants
What treatment does the patient think he/she received (placebo/GON/uncertain)
Time frame: Days 7, 14 and 28
Blinding investigators
What treatment do the investigators think the patient has had
Time frame: Days 7, 14 and 28
Plan to share: No — 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.
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Aug 2021, 24 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylprednisolone
Leiden University Medical Center →