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

StatusRecruiting
PhaseNot specified
Started2025-08-05
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
minor
3 amendments v30-v32
3 re-verifications since 2026-06-26, no change to tracked fields
2026-05-14
minor
Study Status, Contacts/Locations v29
Study sites1→2
2026-04-08
minor
8 amendments v21-v28
8 re-verifications since 2025-09-22, no change to tracked fields
2025-08-28
minor
Study Status v20
Start dateestimated 2025-09-30→confirmed 2025-08-05
2025-07-10
minor
Study Status v19
Re-verified, no change to tracked fields
Show 18 earlier versions
2025-06-27
minor
Study Status v18
Start date2025-07-30→2025-09-30
2025-05-09
minor
Study Status v17
Re-verified, no change to tracked fields
2025-04-02
minor
Study Status v16
Start date2025-04-30→2025-07-30
2025-02-18
minor
Study Status v15
Start date2025-02-03→2025-04-30
2025-01-10
minor
Study Status v14
Re-verified, no change to tracked fields
2024-12-23
minor
Study Status v13
Start date2024-12-01→2025-02-03
2024-11-18
minor
2 amendments v11-v12
2 re-verifications since 2024-10-21, no change to tracked fields
2024-09-27
minor
Study Status v10
Start date2024-10-01→2024-12-01
2024-08-05
minor
Study Status v9
Start date2024-08-30→2024-10-01
2024-06-24
minor
Study Status v8
Start date2024-06-01→2024-08-30
2024-05-15
minor
2 amendments v6-v7
2 re-verifications since 2024-04-09, no change to tracked fields
2024-03-07
minor
Study Status v5
Start date2024-01-31→2024-06-01
2024-02-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-01-24
minor
Study Status v3
Re-verified, no change to tracked fields
2023-12-20
minor
Study Status v2
Start date2023-11-30→2024-01-31
2023-11-21
minor
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2023-10-27
minor
Original filing
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.
Trial Details
NCT Number NCT06113237
Lead Sponsor Jazz Pharmaceuticals
Conditions Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
Enrollment 50 participants
Start Date 2025-08-05
Primary Completion 2033-08-31 (estimated)
Study Completion 2033-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20