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SUNCET: Low sodium oxybate Use for Nocturnal Cluster headache attacks
EU CTIS ID: 2025-523293-17-00
What this study is testing
To evaluate the efficacy of low sodium oxybate (XYWAV) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 in the previous 6 weeks.
- At least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset between the time a participant goes to bed and the time they get out of bed, with a minimum window of 8 hours after bedtime), not exclusively appearing during a single night, but spread across multiple nights.
You likely can't join if
- Suspected of having another trigeminal autonomic cephalalgia (TAC) or other headaches if the patient cannot reliably distinguish them from cluster headache attacks
- Contraindications for using (low) sodium oxybate: o Sleep apnoea syndrome or increased apnoea index (AI > 15/h). o High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5). o Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator. o Porphyria. o Succinic semialdehyde dehydrogenase (SSADH-)deficiency. o Use of opiates, barbiturates, valproic acid, phenytoin, ethosuximide, tricyclic antidepressants, topiramate, (low) sodium oxybate (except for the intervention dose) or sedatives including benzodiazepines during the study. If benzodiazepines are used prior to inclusion, they must be discontinued at least one week before the baseline phase.
- Weight at inclusion of <50kg or >120kg
- Significant pulmonary or neuromuscular diseases in the opinion of the investigator.
- Significant active or unstable psychiatric disease in the opinion of the investigator
- A history of or current indication of substance abuse or substance use disorder
See the full eligibility 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 in the previous 6 weeks.
- At least 4 nocturnal cluster headache attacks per week (defined as occurring after sleep onset between the time a participant goes to bed and the time they get out of bed, with a minimum window of 8 hours after bedtime), not exclusively appearing during a single night, but spread across multiple nights.
- Suspected of having another trigeminal autonomic cephalalgia (TAC) or other headaches if the patient cannot reliably distinguish them from cluster headache attacks
- Contraindications for using (low) sodium oxybate: o Sleep apnoea syndrome or increased apnoea index (AI > 15/h). o High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5). o Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator. o Porphyria. o Succinic semialdehyde dehydrogenase (SSADH-)deficiency. o Use of opiates, barbiturates, valproic acid, phenytoin, ethosuximide, tricyclic antidepressants, topiramate, (low) sodium oxybate (except for the intervention dose) or sedatives including benzodiazepines during the study. If benzodiazepines are used prior to inclusion, they must be discontinued at least one week before the baseline phase.
- Weight at inclusion of <50kg or >120kg
- Significant pulmonary or neuromuscular diseases in the opinion of the investigator.
- Significant active or unstable psychiatric disease 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 6 weeks prior to screening.
- Participation in a clinical trial of an investigation drug or device in the past 30 days
- Women who are pregnant/nursing. Woman of child bearing age need agree to take precautions against becoming pregnant during the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.