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Pregnancy safety of narcolepsy drug pitolisant under scrutiny

NCT ID NCT05536011

Knowledge-focused Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks pregnant women with narcolepsy who take pitolisant (Wakix) or other narcolepsy medications, as well as pregnant women without narcolepsy who take pitolisant. Researchers compare pregnancy outcomes, including birth defects, to see if the drug poses risks. The goal is to gather real-world safety data to guide treatment decisions during pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pitolisant (Wakix)
What this could lead to
If safe, this could provide reassurance for pregnant women needing narcolepsy treatment.
What could go wrong
This is an observational study, not a controlled trial, so it can show associations but not prove cause and effect. Results may take years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,329 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The narcolepsy study population will include three cohorts (cohort 1, 2 and 3) of pregnant women with a diagnosis of narcolepsy: * Cohort 1, exposed to pitolisant at any time during pregnancy * Cohort 2, unexposed to pitolisant or any comparator product at any time during pregnancy * Cohort 3, unexposed to pitolisant but exposed to a comparator product at any time during pregnancy The non-narcolepsy study population will include two cohorts (cohorts 4 and 5) of pregnant women without a diagnosis of narcolepsy: * Cohort 4, exposed to pitolisant at any time during pregnancy * Cohort 5, unexposed to pitolisant but exposed to a comparator product at any time during pregnancy

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant woman of any age * Consent to participate * Authorization for her HCP(s) to provide data to the registry * For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy) * For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy Exclusion Criterion: • Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)

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Conditions

The condition(s) this trial relates to.

narcolepsy pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Narcolepsy Pregnancy related

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Evidera (PPD)

    RECRUITING

    Morrisville, North Carolina, 28403, United States

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