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LSD to Improve Cluster Headache Impact Trial

Study acronym: LICIT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Jul 2026 to Apr 2027
    • Start date: Jan 2025 to Apr 16, 2025
    • Study sites: 0 to 2
    • Study completion date: Aug 2026 to Apr 2027
  2. Primary completion date: Jul 2025 to Jul 2026v4 Show 6 more changesShow less
    • Start date: Jan 2024 to Jan 2025
    • Study completion date: Aug 2025 to Aug 2026
    • Secondary endpoints: 29 to 22
    • Study description shortened, about 172 words
    • Collaborators: 4 to 3
    • Eligibility criteria expanded, about 5 words
  3. Lead sponsor: Canisius-Wilhelmina Hospital to Radboud University Medical Centerv3 Show 7 more changesShow less
    • Start date: May 2023 to Jan 2024
    • Primary completion date: May 2025 to Jul 2025
    • Study completion date: Jul 2025 to Aug 2025
    • Secondary endpoints: 21 to 29
    • Study description expanded, about 157 words
    • Collaborators: 3 to 4
    • Study title shortened, about 2 words
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH). It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period. Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH. Additional objectives: * To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. * To explore the exposure-response relationship of 25μg LSD in cCH. * To explore cost-effectiveness of treatment with LSD in cCH. * To evaluate the efficacy of LSD on health-related quality of life.
Trial Details
NCT Number NCT05477459
Lead Sponsor Radboud University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Canisius-Wilhelmina Hospital, Leiden University Medical Center
Conditions
(from sponsor)		 Chronic Cluster Headache
Related terms Cluster Headache
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov