Status:
NOT_YET_RECRUITING
Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks
Lead Sponsor:
Leiden University Medical Center
Conditions:
Chronic Cluster Headache
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 hea...
Detailed Description
The exact aetiology of cluster headache remains unknown and fundamental questions are still unanswered. However, the tendency of cluster headache attacks to occur during sleep suggests a pivotal role ...
Eligibility Criteria
Inclusion
- 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 pregnant/breastfeeding. Woman of childbearing age need to agree to sufficient contraception during the trial.
- Contraindications for using LXB:
- Sleep apnoea syndrome or increased apnoea index (AI \> 15/h).
- High risk of sleep apnoea syndrome, indicated by the STOP-Bang questionnaire (score ≥ 5).
- Currently suffering from severe depression and using medication or receiving cognitive therapy. Final choice is at the discretion of the principal investigator.
- Porphyria.
- Succinic semialdehyde dehydrogenase (SSADH-)deficiency.
- Use of opiates, barbiturates, valproic acid, phenytoin, ethosuximide, tricyclic antidepressants, topiramate, LXB (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.
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06950281
Start Date
January 1 2026
End Date
May 1 2028
Last Update
November 24 2025
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