NarcolepsyNCT01792583
The Nuvigil and Provigil Pregnancy Registry
An observational study of Narcolepsy and Obstructive Sleep Apnea, run by Cephalon, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- What is being tested?
- Modafinil/armodafinil
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2009to 30 Nov 2023
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Registry is conducted in the US and includes female patients exposed to modafinil and/or armodafinil within 6 weeks prior to becoming pregnant or any time during pregnancy. The Registry is designed for open enrollment of all patients meeting the inclusion/exclusion criteria. Registry enrollment is initiated by either patients or healthcare professionals. Patients who meet the eligibility criteria and provide informed consent will be enrolled into the study.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Teva Pregnancy Registry
West Chester, Pennsylvania, 19380
About this study
Official title: 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.
Read the detailed description
Both the prospective and the retrospective data are captured.
- Being tested
- Modafinil/armodafinil
- Keywords
- pregnancy
- Medical subject headings
- Narcolepsy, Sleep Apnea, Obstructive, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modafinil/armodafinilDrug
Also called Provigil, Nuvigil
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Modafinil/armodafinil | |
| 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 examination. Receives: Drug: Modafinil/armodafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major birth defects
Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions
Measured: End of pregnancy through the first year after delivery
Secondary outcomes (12)
Incidence of minor birth defects
Measured: 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
Measured: Baseline and End of pregnancy
Incidence of spontaneous abortion (defined as <20 weeks gestation)
Measured: Baseline and End of pregnancy
Incidence of fetal death (defined as >=20 weeks gestation
Measured: Baseline and End of pregnancy
Incidence of neurodevelopmental problems
Measured: Baseline and End of pregnancy
Incidence of Microcephaly
Measured: End of pregnancy
Incidence of small size for gestational age
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
Measured: End of pregnancy
Incidence of intrauterine growth restriction (IUGR)
defined as observed fetal weight or birth weight below the 10th percentile for gestational age
Measured: End of pregnancy
Incidence of Low/very low birth weight (LBW/VLBW)
Defines as - Low birth weight: <2500 g, regardless of gestational age and - Very low birth weight: birth weight <1500 g, regardless of gestational age
Measured: End of pregnancy
Incidence of Preterm delivery
Measured: End of pregnancy
Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)
Measured: Baseline through End of pregnancy
Maternal breastmilk feeding practices
Measured: End of pregnancy through the first year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start30 Jun 2009
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: The study is no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 191 participants (actual)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Cephalon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792583
- Sponsor's protocol ID
- C10953/9022
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2013
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01792583
- Acronym / sponsor ID
- C10953/9022
- Keywords
- pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study is no longer feasible.
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Cephalon, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both the prospective and the retrospective data are captured.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 21 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Drug: Modafinil/armodafinilProspective 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). |
| Retrospective Cohort | – | Drug: Modafinil/armodafinilRetrospective 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Registry is conducted in the US and includes female patients exposed to modafinil and/or armodafinil within 6 weeks prior to becoming pregnant or any time during pregnancy. The Registry is designed for open enrollment of all patients meeting the inclusion/exclusion criteria. Registry enrollment is initiated by either patients or healthcare professionals. Patients who meet the eligibility criteria and provide informed consent will be enrolled into the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil/armodafinilAlso: Provigil, Nuvigil | Drug | Prospective Cohort, Retrospective Cohort |
Primary outcome
Incidence of major birth defects
Time frame: End of pregnancy through the first year after delivery
Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions
12 secondary outcomes
Incidence of minor birth defects
Time frame: 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
Time frame: Baseline and End of pregnancy
Incidence of spontaneous abortion (defined as <20 weeks gestation)
Time frame: Baseline and End of pregnancy
Incidence of fetal death (defined as >=20 weeks gestation
Time frame: Baseline and End of pregnancy
Incidence of neurodevelopmental problems
Time frame: Baseline and End of pregnancy
Incidence of Microcephaly
Time frame: End of pregnancy
Incidence of small size for gestational age
Time frame: End of pregnancy
Incidence of intrauterine growth restriction (IUGR)
Time frame: End of pregnancy
Incidence of Low/very low birth weight (LBW/VLBW)
Time frame: End of pregnancy
Incidence of Preterm delivery
Time frame: End of pregnancy
Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)
Time frame: Baseline through End of pregnancy
Maternal breastmilk feeding practices
Time frame: End of pregnancy through the first year after delivery
Results and safety
The study was stopped early (reason given: The study is no longer feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy and Obstructive Sleep Apnea, run by Cephalon, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study is no longer feasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major birth defects (time frame: End of pregnancy through the first year after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.