NCT04485104Phase 3Terminated

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

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 completion2025-01-28Actual

Enrollment · participants3Actual

Source updated2025-10-31Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Seizure in Participants With Tuberous Sclerosis Complex; Seizure in Participants With Dravet Syndrome; Seizure in Participants With Lennox-Gastaut Syndrome

Treatments or interventions studied

GWP42003-PDrugAlso known as Cannabidiol, Epidiolex, Epidyolex

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); timeFrame: From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks; measure: Mean Change From Baseline in Blood Pressure; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Pulse Rate; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Respiratory Rate; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Body Temperature; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Height; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Body Weight; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in Heart Rate; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in RR Interval; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in PR Interval; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in QRS Duration; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in QT Interval; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Mean Change From Baseline in QTcB and QTcF; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Number of Participants With a Clinically Significant Change in Laboratory Parameters; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Number of Participants With Emergence of New Types of Seizures; timeFrame: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks; measure: Plasma Concentrations of GWP42003-P and Its Major Metabolites; timeFrame: Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52); measure: Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers; timeFrame: Day 1 up to Taper Period, up to Week 52; measure: Clinician Global Impression of Severity (CGI/S) Score; description: The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.; timeFrame: At Day 365 (EOT); measure: Clinician Global Impression of Change (CGI/C) Score; description: The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome.; timeFrame: At Day 365 (EOT)

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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