NCT05288283Phase 3Terminated

Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-28Actual

Enrollment · participants3Actual

Source updated2025-02-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Seizures Associated With EMAS

Treatments or interventions studied

GWP42003-PDrugAlso known as EPIDIOLEX, Cannabidiol, Cannabidiol oral solution (CBD-OS)
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Part A: Percent Change From Baseline in Epilepsy With Myoclonic-atonic Seizures (EMAS) Associated Seizure Frequency (Myoclonic-atonic, Atonic, Tonic, Clonic, or Tonic-clonic) Over the 14-week Treatment Period; timeFrame: Baseline; up to 14 weeks; measure: Part B: Number of Participants With Treatment-emergent Adverse Events; timeFrame: up to Week 54; measure: Part B: Number of Participants With Clinically Significant Vital Sign Values; timeFrame: up to Week 50; measure: Part B: Number of Participants With Clinically Significant Physical Examination Values; timeFrame: up to Week 48; measure: Part B: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Values; timeFrame: up to Week 48; measure: Part B: Number of Participants With Clinically Significant Laboratory Test Values; timeFrame: up to Week 48; measure: Part B: Number of Participants With Changes in Tanner Staging; timeFrame: up to Week 48; measure: Part B: Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Ideation Scores; timeFrame: up to Week 54; measure: Part B: Number of Participants With a Change in the Number of Suicide Attempts Per C-SSRS Scores; timeFrame: up to Week 54

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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