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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: Clinical Trial Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT04485104 is a Phase 3 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 3 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT04485104 stopped before completion
NCT04485104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which GWP42003-P is the first listed.
NCT04485104 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04485104's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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