Pregnancy safety of narcolepsy drug pitolisant under scrutiny
NCT ID NCT05536011
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.
Disclaimer
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the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Evidera (PPD)
RECRUITINGMorrisville, North Carolina, 28403, United States
Contact