Stopped: The study was terminated by the Sponsor due to low patient enrollment.
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).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
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
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
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
Mean Change From Baseline in Height
Timeframe: From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks
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
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
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
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
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
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
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
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
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
Plasma Concentrations of GWP42003-P and Its Major Metabolites
Timeframe: Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52)
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
Clinician Global Impression of Severity (CGI/S) Score
Timeframe: At Day 365 (EOT)
Clinician Global Impression of Change (CGI/C) Score
Timeframe: At Day 365 (EOT)