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Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy

NCT ID: NCT06113237

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-05

Study Completion Date

2033-08-31

Brief Summary

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The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.

Detailed Description

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Conditions

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Maternal Complications Pregnancy Complication Birth Outcomes, Adverse Pregnancy

Keywords

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Epidiolex Epidyolex

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective Pregnancy

Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.

Epidiolex

Intervention Type DRUG

Oral solution

Prospective Pregnancy

Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.

Epidiolex

Intervention Type DRUG

Oral solution

Interventions

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Epidiolex

Oral solution

Intervention Type DRUG

Other Intervention Names

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Epidyolex Cannabidiol

Eligibility Criteria

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Inclusion Criteria

1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy.
2. Verbal or written informed consent to participate

Exclusion Criteria

1\) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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United Biosource LLC

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trial Disclosure & Transparency

Role: CONTACT

Phone: 215-832-3750

Email: [email protected]

Other Identifiers

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GWEP21095

Identifier Type: -

Identifier Source: org_study_id