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Retrospective Pregnancy for Pregnancy Complications

N/A
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post birth
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Maternal Complications
  • Pregnancy Complications
  • Adverse Birth Outcomes
  • Pregnancy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of MCM
Secondary outcome measures
Rate of maternal complications during pregnancy
Rate of other events of interest in the developing neonate and infant
Rate of pregnancy outcomes

Side effects data

From 2022 Phase 1 & 2 trial • 3 Patients • NCT04238754
67%
Abdominal Pain
33%
Drowsiness
33%
Nausea
33%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epidiolex
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Retrospective PregnancyExperimental Treatment1 Intervention
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.
Group II: Prospective PregnancyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epidiolex
2020
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,309 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
2024. "Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113237.
All > Paid Studies Pittsburgh
~33 spots leftby Aug 2033
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