| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set. | Posted | | Number | | participants | | From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Blood Pressure | | Blood pressure was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | mmHg | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Pulse Rate | | Pulse rate was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | beats per minute | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Respiratory Rate | | Respiratory rate was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | breaths/minute | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Body Temperature | | Body temperature was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | degrees Celsius | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Height | | Height was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | centimeters | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Body Weight | | Body weight was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | kilogram | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in Heart Rate | | Heart rate was assessed in participants with available data in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | beats/minute | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in RR Interval | | RR interval was assessed in participants with available data in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | millisecond | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in PR Interval | | PR interval was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | millisecond | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in QRS Duration | | QRS duration was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | millisecond | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in QT Interval | | QT interval was assessed in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | millisecond | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Mean Change From Baseline in QTcB and QTcF | | QTcB and QTcF were assessed in participants with available data in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | millisecond | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Number of Participants With a Clinically Significant Change in Laboratory Parameters | | Clinically significant change in laboratory parameters were assessed in participants with available data in the Safety Analysis Set. | Posted | | Number | | participants | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Number of Participants With Emergence of New Types of Seizures | | New types of seizures were assessed in the Safety Analysis Set. | Posted | | Number | | participants | | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Plasma Concentrations of GWP42003-P and Its Major Metabolites | | Pharmacokinetics were assessed and reported for participants when samples were collected. For both participants with Tuberous Sclerosis Complex, it was not possible to collect PK samples at 6hr post dose. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52) | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers | | Indication-specific total countable seizures where assessed in the Safety Analysis Set. | Posted | | Number | | participants | | Day 1 up to Taper Period, up to Week 52 | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Clinician Global Impression of Severity (CGI/S) Score | 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. | CGI-S was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI S, this assessment was not collected for these participants. | Posted | | Mean | Standard Deviation | score on a scale | | At Day 365 (EOT) | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Primary | Clinician Global Impression of Change (CGI/C) Score | 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. | CGI-C was assessed and reported for the participant with Dravet Syndrome. As both participants with Tuberous Sclerosis Complex consented under a previous protocol version that did not include CGI-C, this assessment was not collected for these participants. | Posted | | Mean | Standard Deviation | score on a scale | | At Day 365 (EOT) | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Other Pre-specified | Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) Score | The Infant and Toddler Quality of Life Questionnaire Short Form 47 (ITQOL-47) was developed for use in infants and toddlers from 12-months-to-5 years of age and assesses levels of health and well-being. The caregiver will complete the assessment on an electronic device. For each concept, item responses are scored, summed, and transformed on a scale from 0 (worst health) to 100 (best health). Higher scores indicate better clinical outcome. | ITQOL-47 score was assessed in participants with available data in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | score on a scale | | At Day 365 (EOT) | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Secondary | Number of Treatment Responders | Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures | Treatment response was assessed and reported for participants with available data. The participant with Dravet Syndrome was not assessed at the last 3 timepoints due to early withdrawal from the study. | Posted | | Number | | participants | | Day 1 up to the taper period, up to Week 52 | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Other Pre-specified | Percentage Change From Baseline in Indication-Specific Seizure Frequency As Recorded by Caregivers | | Seizure frequency was assessed in participants with available data in the Safety Analysis Set. | Posted | | Mean | Standard Deviation | seizure frequency | | Day 1 up to Taper Period, up to Week 52 | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Secondary | Number of Participants Who Achieved Seizure-Free Status | | Seizure free status is reported for the 2 participants that remained on the study for > 12 weeks, and data are reported up to the timepoint prior to their withdrawal from the study. One participant with Tuberous Sclerosis Complex withdrew from the study prior to week 12 so their seizure free status could not be assessed. | Posted | | Number | | participants | | Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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| Secondary | Percentage of Participants Still Receiving GWP42003-P | | Percentage of participants still receiving GWP42003-P is reported to the point at which subjects terminated their treatment and withdrew from the study. One participant with Tuberous Sclerosis Complex withdrew from the study prior to week 12. One participant with Tuberous Sclerosis Complex withdrew following the Day 170-197 timepoint. The participant with Dravet Syndrome withdrew following the Day 142-169 timepoint. | Posted | | Number | | percentage of participants | | Week 12, and every 4 weeks thereafter, up to date of withdrawal or Week 24, whichever occurs first | | | | ID | Title | Description |
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| OG000 | Tuberous Sclerosis Complex | Participants with Tuberous Sclerosis Complex who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. | | OG001 | Dravet Syndrome | Participants with Dravet Syndrome who received GWP42003-P orally twice daily (b.i.d.) on a titration schedule, with a starting dose of 5 mg/kg/day (2.5 mg/kg b.i.d.) on Day 1, then 10 mg/kg/day (5 mg/kg b.i.d.) on Day 8, followed by a flexible dose optimization from Day 15 to Week 52 based on the clinical judgment of the investigator. |
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