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ACTIVE NOT RECRUITING Phase 4

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

NCT05864846 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

Interventions

  • DRUG Cannabidiol Oral Solution [Epidiolex]

Study Locations (19)

Other

  • The Children's Memorial Health Institute — Warsaw
  • University Hospitals Bristol NHS Foundation Trust — Bristol
  • Sheffield Children's NHS Foundation Trust — Sheffield

Florida

  • University of Florida Health - Department of Neurology — Gainesville
  • Nicklaus Children's Health, Miami — Miami

Texas

  • University of Texas Health Science Center at Houston - Clinical Research Unit — Houston
  • University of Texas Health Science Center - San Antonio — San Antonio

Colorado

  • Children's Hospital Colorado — Aurora

Connecticut

  • Yale University School of Medicine — New Haven

Massachusetts

  • Massachusetts General Hospital — Boston

Minnesota

  • Minnesota Epilepsy Group — Roseville

North Carolina

  • Atrium Health Wake Forest Baptist Medical Center — Winston-Salem

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2023-06-29
Est. Completion 2026-03-26
Phase Phase 4

Sponsor

Jazz Pharmaceuticals

37 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05864846

The ClinicalTrials.gov registry entry for NCT05864846 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Tuberous Sclerosis Complex Associated Neuropsychiatric Disease appearing as the primary indexed condition, and to 1 intervention — of which Cannabidiol Oral Solution [Epidiolex] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05864846 reports 19 study locations spanning 15 distinct geographic areas — top geographies include Other, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05864846 about?

NCT05864846 is a clinical study titled "A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex". The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

What is the current status of trial NCT05864846?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 79 participants. The study started on 2023-06-29. Estimated completion is 2026-03-26.

What conditions does trial NCT05864846 study?

This clinical trial studies the following conditions: Tuberous Sclerosis Complex Associated Neuropsychiatric Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05864846?

The interventions under investigation include: Cannabidiol Oral Solution [Epidiolex] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05864846?

This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05864846 being conducted?

This trial has 19 study locations across Colorado, Connecticut, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial