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).
Age range
1 Month – 23 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)