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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05536011
The ClinicalTrials.gov registry entry for NCT05536011 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,329 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,950-participant average among 99 other Pregnancy Related trials with a reported enrollment target (32% lower). The listed sponsor is Harmony Biosciences Management, which has 10 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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