The Nuvigil and Provigil Pregnancy Registry
Megadott ok: The study is no longer feasible.
A legfontosabb adatok
- Hol
- West Chester (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Teva Pregnancy RegistryWest Chester, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Cephalon, Inc.
- Azonosító
- NCT01792583
- A regiszteradat frissítve
- 2024. február 5.
- Eredeti leírás
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.A teljes eredeti leírásKevesebb
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
Bevonási feltételek: Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy; Patients who provide oral or written informed consent; Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff.
Kizáró feltételek: Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Patients who refuse to provide oral or written informed consent.