The Nuvigil and Provigil Pregnancy Registry

Cephalon

Status: Terminated

Conditions: Shift Work Sleep Disorder; Obstructive Sleep Apnea; Narcolepsy

Treatments: Drug: Modafinil/armodafinil

Study type: Observational

Funder types: Industry

Identifiers

NCT01792583

C10953/9022

Details and patient eligibility

About

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.

Full description

Both the prospective and the retrospective data are captured.

Enrollment: 191 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients who refuse to provide oral or written informed consent.
• 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.

Trial design

191 participants in 2 patient groups

Prospective Cohort

Description:

Prospective is defined per protocol: prospective data of pregnancy exposure are data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination (e.g. fetal ultrasound, serum markers).

Treatment:

Drug: Modafinil/armodafinil

Retrospective Cohort

Description:

Retrospective is defined per protocol: retrospective data of pregnancy exposure are data acquired after the outcome of the pregnancy is known or after the detection of a congenital malformation on prenatal examination.

Treatment:

Drug: Modafinil/armodafinil