Pregnancy RelatedNCT05536011
WAKIX® (Pitolisant) Pregnancy Registry
An observational study of Pregnancy Related and Narcolepsy, run by Harmony Biosciences Management, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Related, Narcolepsy
- What is being tested?
- Pitolisant and Comparator Products
- How many people
- 1,329 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2021to 30 Jun 2030
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Evidera (PPD)
Morrisville, North Carolina, 28403
Marielle Bassell, BA
About this study
Official title: WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
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.
Read the detailed description
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. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.
- Conditions
- Pregnancy Related, Narcolepsy
- Being tested
- Pitolisant, Comparator Products
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitolisantDrug
Also called Wakix
Exposure to at least one dose of pitolisant at any time during pregnancy
Comparator ProductsDrug
Also called Modafinil/armodafinil, Sodium oxybate, Oxybate mixed salts, Solriamfetol
Exposure to at least one dose of a comparator product at any time during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant-exposed participants with narcolepsy | Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy Receives: Drug: Pitolisant | |
| Unexposed participants with narcolepsy | Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy | |
| Comparator-exposed participants with narcolepsy | Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to comparator products at any time during pregnancy Receives: Drug: Comparator Products | |
| Pitolisant-exposed participants without narcolepsy | Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy Receives: Drug: Pitolisant | |
| Comparator-exposed participants without narcolepsy | Pregnant women without a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to a comparator product at any time during pregnancy Receives: Drug: Comparator Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major congenital malformation
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.
Measured: Enrollment through the infant's first year of life
Secondary outcomes (10)
Minor congenital malformation
An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.
Measured: Enrollment through the infant's first year of life
Pre-eclampsia
High blood pressure and signs of liver or kidney damage occurring at >20 gestational weeks.
Measured: Enrollment through pregnancy outcome
Eclampsia
Seizures or coma in a pregnant woman with pre-eclampsia.
Measured: Enrollment through pregnancy outcome
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.
Measured: Enrollment through pregnancy outcome
Stillbirth
As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Measured: Enrollment through pregnancy outcome
Elective termination
A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.
Measured: Enrollment through pregnancy outcome
Preterm birth
A live birth occurring at <37 gestational weeks.
Measured: Enrollment through the infant's first year of life
Small for gestational age
Weight, length, or head circumference at birth in <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Measured: Enrollment through the infant's first year of life
Postnatal growth deficiency
Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts
Measured: Enrollment through the infant's first year of life
Infant development deficiency
Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC).
Measured: Enrollment through the infant's first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start24 Aug 2021
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,329 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536011
- Sponsor's protocol ID
- HBS-101-CL-008
- Status last verified
- Jun 2026
- First submitted
- 7 Sep 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT05536011
- Acronym / sponsor ID
- HBS-101-CL-008
- Conditions
- Pregnancy Related, Narcolepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,329 participants (estimated)
- Lead sponsor
- Harmony Biosciences Management, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pitolisant-exposed participants with narcolepsy | – | Drug: PitolisantPregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy |
| Unexposed participants with narcolepsy | – | –Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy |
| Comparator-exposed participants with narcolepsy | – | Drug: Comparator ProductsPregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to comparator products at any time during pregnancy |
| Pitolisant-exposed participants without narcolepsy | – | Drug: PitolisantPregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy |
| Comparator-exposed participants without narcolepsy | – | Drug: Comparator ProductsPregnant women without a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to a comparator product at any time during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitolisantAlso: WakixExposure to at least one dose of pitolisant at any time during pregnancy | Drug | Pitolisant-exposed participants with narcolepsy, Pitolisant-exposed participants without narcolepsy |
| Comparator ProductsAlso: Modafinil/armodafinil, Sodium oxybate, Oxybate mixed salts, SolriamfetolExposure to at least one dose of a comparator product at any time during pregnancy | Drug | Comparator-exposed participants with narcolepsy, Comparator-exposed participants without narcolepsy |
Primary outcome
Major congenital malformation
Time frame: Enrollment through the infant's first year of life
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.
10 secondary outcomes
Minor congenital malformation
Time frame: Enrollment through the infant's first year of life
Pre-eclampsia
Time frame: Enrollment through pregnancy outcome
Eclampsia
Time frame: Enrollment through pregnancy outcome
Spontaneous abortion
Time frame: Enrollment through pregnancy outcome
Stillbirth
Time frame: Enrollment through pregnancy outcome
Elective termination
Time frame: Enrollment through pregnancy outcome
Preterm birth
Time frame: Enrollment through the infant's first year of life
Small for gestational age
Time frame: Enrollment through the infant's first year of life
Postnatal growth deficiency
Time frame: Enrollment through the infant's first year of life
Infant development deficiency
Time frame: Enrollment through the infant's first year of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Narcolepsy, run by Harmony Biosciences Management, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WAKIX Pregnancy Registry Associate (1-877-302-2813, wakixpregnancyregistry@ppd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformation (time frame: Enrollment through the infant's first year of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.