The Nuvigil and Provigil Pregnancy Registry

Sponsor

Cephalon, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01792583

Collaborator

(none)

300

Enrollment

Location

211.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy Obstructive Sleep Apnea Shift Work Sleep Disorder	Drug: Modafinil/armodafinil

Detailed Description

Both the prospective and the retrospective data are captured.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry

Actual Study Start Date :

Jun 30, 2009

Anticipated Primary Completion Date :

Jan 31, 2027

Anticipated Study Completion Date :

Jan 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Prospective Cohort 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).	Drug: Modafinil/armodafinil Other Names: Provigil Nuvigil
Retrospective Cohort 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 test.	Drug: Modafinil/armodafinil Other Names: Provigil Nuvigil

Arm

Intervention/Treatment

Prospective Cohort

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).

Drug: Modafinil/armodafinil

Other Names:

Provigil

Nuvigil

Retrospective Cohort

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 test.

Drug: Modafinil/armodafinil

Other Names:

Provigil

Nuvigil

Outcome Measures

Primary Outcome Measures

Incidence of major birth defects [End of pregnancy through the first year after delivery]
Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions

Secondary Outcome Measures

Incidence of minor birth defects [End of pregnancy through the first year after delivery]
Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect [Baseline and End of pregnancy]
Incidence of spontaneous abortion (defined as <20 weeks gestation) [Baseline and End of pregnancy]
Incidence of fetal death (defined as >=20 weeks gestation [Baseline and End of pregnancy]
Incidence of neurodevelopmental problems [Baseline and End of pregnancy]
Incidence of Microcephaly [End of pregnancy]
Incidence of small size for gestational age [End of pregnancy]
defined as the observed weight of a live born infant or size of a fetus that is lower than expected on the basis of gestational age
Incidence of intrauterine growth restriction (IUGR) [End of pregnancy]
defined as observed fetal weight or birth weight below the 10th percentile for gestational age
Incidence of Low/very low birth weight (LBW/VLBW) [End of pregnancy]
Defines as - Low birth weight: <2500 g, regardless of gestational age and - Very low birth weight: birth weight <1500 g, regardless of gestational age
Incidence of Preterm delivery [End of pregnancy]
Incidence of Preeclampsia/pregnancy-induced hypertension (PIH) [Baseline through End of pregnancy]
Maternal breastmilk feeding practices [End of pregnancy through the first year after delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.