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Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks

Study acronym: SUNCET
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2027 → Dec 2028
See other at-risk trials from Leiden University Medical Center

Record History

  1. Primary completion pushed from Dec 2027 to Dec 2028 Start date: Jan 2026 to Dec 2026 · Completion pushed from May 2028 to May 2029 · Study description expanded, about 21 wordsv3 Show 3 more changesShow less
    • Start date: Jan 2026 to Dec 2026
    • Completion pushed from May 2028 to May 2029
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint revised Enrollment target: 60 to 52 · Start date: Dec 2025 to Jan 2026 · Eligibility criteria expanded, about 33 words · 2 morev2 Show 5 more changesShow less
    • Enrollment target: 60 to 52
    • Start date: Dec 2025 to Jan 2026
    • Eligibility criteria expanded, about 33 words
    • Study description revised
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 a 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.
Trial Details
NCT Number NCT06950281
Lead Sponsor Leiden University Medical Center
Conditions Chronic Cluster Headache
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov