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Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Mar 1, 2026 to Oct 1, 2026
    • Primary and study completion dates: Jul 31, 2027 to Sep 30, 2027
    v4
  2. Primary and study completion dates: Jul 31, 2026 to Jul 31, 2027v3
  3. Start date: Aug 1, 2025 to Mar 1, 2026v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Using a comprehensive approach of clinico-behavioral testing and neuroimaging, the researchers will examine the clinical effects of the extended-release formulation of sodium oxybate on voice symptoms in spasmodic dysphonia in an open-label, proof-of-concept, dose-finding study.
Trial Details
NCT Number NCT07041203
Lead Sponsor Kristina Simonyan
Conditions
(from sponsor)		 Spasmodic Dysphonia, Laryngeal Dystonia, Voice Tremor
Related terms Dysphonia
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov