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WAKIX® (Pitolisant) Pregnancy Registry

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv4
  2. 2 versions Re-verified since Jan 24, 2024, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Trial Details
NCT Number NCT05536011
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions
(from sponsor)		 Pregnancy Related, Narcolepsy
Related terms Narcolepsy
Enrollment 1,329 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov