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NCT05536011 · ClinicalTrials.gov registry record
WAKIX® (Pitolisant) Pregnancy Registry
A clinical trial of Pregnancy Related and Narcolepsy, sponsored by Harmony Biosciences Management.
- Recruiting
- Registry status
- 1,329
- Enrollment target
- 1
- Study location
NCT05536011: Recruiting study of Pregnancy Related and Narcolepsy, sponsored by Harmony Biosciences Management.
NCT05536011 is a study of Pregnancy Related and Narcolepsy that is actively recruiting participants, run by Harmony Biosciences Management. The registered enrollment target is 1,329 participants, below the 1,950-participant average among 99 other Pregnancy Related trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05536011, a study of Pregnancy Related and Narcolepsy, is actively recruiting participants, sponsored by Harmony Biosciences Management.
- RECRUITING
- Registry status
- 1,329 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
Conditions Studied
Interventions
- DRUG Pitolisant
- DRUG Comparator Products
Study Locations (1)
North Carolina
- Evidera (PPD) - Morrisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,329 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2030-06-30 |
What NCT05536011 shows while recruiting
NCT05536011 is an observational study that tracks outcomes without assigning an intervention. Its 1,329 participants enrollment target places it among the larger protocols in the corpus, below the 1,950-participant average among 99 other Pregnancy Related trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which Pitolisant is the first listed.
NCT05536011 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05536011 about?
NCT05536011 is a clinical study titled "WAKIX® (Pitolisant) Pregnancy Registry". 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.
What is the current status of trial NCT05536011?
This trial is currently recruiting. The enrollment target is 1,329 participants. The study started on 2021-08-24. Estimated completion is 2030-06-30.
What conditions does trial NCT05536011 study?
This clinical trial studies the following conditions: Pregnancy Related, Narcolepsy.
What interventions are being tested in trial NCT05536011?
The interventions under investigation include: Pitolisant (DRUG), Comparator Products (DRUG).
Who is sponsoring clinical trial NCT05536011?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05536011 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05536011's enrollment target sits among peer trials
1,329 12th of 99 higher than 88 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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