Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks (NCT06950281) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks
52 participantsStarted 2026-01
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.
It is an 16 week, randomized, double-blind, placebo- controlled, bi-center trial.
LXB will be administered as a twice nightly regimen. All subjects will undergo an 6 week Treatment Titration and Optimization Phase.
The main trial endpoint is the change from baseline in average weekly frequency of nocturnal cluster headache attacks over 4-week fixed stable dose of treatment period.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
Age ≥18 and ≤75 at the time of consent.
Diagnosed with chronic cluster headache according to the International Classification of Headache Disorders (ICHD-III) criteria.
Free of other cluster headache prophylactic medication OR on stable dose for at least 4 weeks.
Not having received a GON (Greater Occipital Nerve) injection or oral prednisone in the previous 3 months.
At least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset during the night between 22:00 and 08:00), not exclusively appearing during a single night, but spread across multiple nights.
Exclusion criteria
Suspected of having another trigeminal autonomic cephalalgia (TAC).
Other headaches if the patient cannot reliably distinguish them from cluster headache attacks.
Weight at inclusion of \<50kg or \>120kg.
Significant active or unstable psychiatric disease in the opinion of the investigator.
Significant pulmonary or neuromuscular diseases in the opinion of the investigator.
A history of or current indication of substance abuse or substance use disorder.
Unwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm.
Stimulator devices which could influence sleep or cluster headache symptoms, such as an occipital nerve stimulator (ONS), when settings have not been stable for at least three months prior to screening.
Participation in a clinical trial of an investigation drug or device in the past 30 days.
Women who are…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in average weekly frequency of nocturnal cluster headache attacks (verum vs placebo)
Timeframe: During 4-week fixed stable dose treatment phase