WAKIX® (Pitolisant) Pregnancy Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorHarmony Biosciences Management, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pitolisant
DrugExposure to at least one dose of pitolisant at any time during pregnancy
Comparator Products
DrugExposure to at least one dose of a comparator product at any time during pregnancy
Treatment groups
1,329 Participants
are divided into 5 treatment groupsGroup A: Pitolisant-exposed participants with narcolepsy1 intervention
Group B: Unexposed participants with narcolepsy0 interventions
Group C: Comparator-exposed participants with narcolepsy1 intervention
Group D: Pitolisant-exposed participants without narcolepsy1 intervention
Group E: Comparator-exposed participants without narcolepsy1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Enrollment through the infant's first year of lifeSecondary outcomes
1
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.
Time frame
Enrollment through the infant's first year of life2
Pre-eclampsia
High blood pressure and signs of liver or kidney damage occurring at \>20 gestational weeks.
Time frame
Enrollment through pregnancy outcome3
Eclampsia
Seizures or coma in a pregnant woman with pre-eclampsia.
Time frame
Enrollment through pregnancy outcome4
Spontaneous abortion
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks.
Time frame
Enrollment through pregnancy outcomeSponsors and contacts
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Source ClinicalTrials.gov