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NCT04485104 · ClinicalTrials.gov registry record · Phase 3
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT04485104 is a Phase 3 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 3 participants.
The verdict
NCT04485104, a Phase 3 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
Interventions
- DRUG GWP42003-P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2025-01-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04485104
The ClinicalTrials.gov registry entry for NCT04485104 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GWP42003-P is the first listed.
NCT04485104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04485104 about?
NCT04485104 is a clinical study titled "Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures". This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
What is the current status of trial NCT04485104?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2021-05-19. Estimated completion is 2025-01-28.
What interventions are being tested in trial NCT04485104?
The interventions under investigation include: GWP42003-P (DRUG).
Who is sponsoring clinical trial NCT04485104?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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