Trial Outcomes & Findings for A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) (NCT NCT02091206)

NCT ID: NCT02091206

Last Updated: 2022-09-28

Results Overview

A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline (Day 1) through Safety follow-up visit (Day 60)

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	GWP42003-P 5 mg/kg/Day Dose Participants received GWP42003-P 5 milligrams (mg) per kilogram (kg) per day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo Participants received placebo (0 mg/milliliter \[mL\] cannabidiol \[CBD\]), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Treatment Period STARTED	10	8	9	7
Treatment Period Safety Analysis Set	10	8	9	7
Treatment Period COMPLETED	10	7	8	7
Treatment Period NOT COMPLETED	0	1	1	0
Taper Period STARTED	10	7	8	7
Taper Period COMPLETED	9	7	8	5
Taper Period NOT COMPLETED	1	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	GWP42003-P 5 mg/kg/Day Dose Participants received GWP42003-P 5 milligrams (mg) per kilogram (kg) per day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo Participants received placebo (0 mg/milliliter \[mL\] cannabidiol \[CBD\]), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Treatment Period Adverse Event	0	1	0	0
Treatment Period Met withdrawal criteria	0	0	1	0
Taper Period Participant refused study drug	1	0	0	1
Taper Period Lost to Follow-up	0	0	0	1

Baseline Characteristics

A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GWP42003-P 5 mg/kg/Day Dose n=10 Participants Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose n=8 Participants Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose n=9 Participants Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo n=7 Participants Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.	Total n=34 Participants Total of all reporting groups
Age, Continuous	7.150 Years STANDARD_DEVIATION 1.8955 • n=5 Participants	7.368 Years STANDARD_DEVIATION 2.1229 • n=7 Participants	8.671 Years STANDARD_DEVIATION 1.7957 • n=5 Participants	6.978 Years STANDARD_DEVIATION 0.9476 • n=4 Participants	7.568 Years STANDARD_DEVIATION 1.8300 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) through Safety follow-up visit (Day 60)

Population: Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.

Outcome measures

Outcome measures
Measure	GWP42003-P 5 mg/kg/Day Dose n=10 Participants Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose n=8 Participants Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose n=9 Participants Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo n=7 Participants Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)	2 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Predose and 2-6 hours postdose on Days 1 and 22

AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation.

Outcome measures

Outcome measures
Measure	GWP42003-P 5 mg/kg/Day Dose n=10 Participants Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose n=8 Participants Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose n=9 Participants Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 1 CBD	70.61 hours * nanograms/mL Geometric Coefficient of Variation 20.38	66.35 hours * nanograms/mL Geometric Coefficient of Variation 120.8	73.69 hours * nanograms/mL Geometric Coefficient of Variation 96.64	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 22 CBD	240.8 hours * nanograms/mL Geometric Coefficient of Variation 100.8	721.8 hours * nanograms/mL Geometric Coefficient of Variation 79.92	962.6 hours * nanograms/mL Geometric Coefficient of Variation 93.43	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 1 6-OH-CBD	3.27 hours * nanograms/mL Geometric Coefficient of Variation 132	2.79 hours * nanograms/mL Geometric Coefficient of Variation 87.7	5.16 hours * nanograms/mL Geometric Coefficient of Variation 57.2	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 22 6-OH-CBD	9.33 hours * nanograms/mL Geometric Coefficient of Variation 119	26.3 hours * nanograms/mL Geometric Coefficient of Variation 82.9	58.6 hours * nanograms/mL Geometric Coefficient of Variation 90.1	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 1 7-OH-CBD	21.9 hours * nanograms/mL Geometric Coefficient of Variation 57.0	18.4 hours * nanograms/mL Geometric Coefficient of Variation 299	30.2 hours * nanograms/mL Geometric Coefficient of Variation 105	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 22 7-OH-CBD	131 hours * nanograms/mL Geometric Coefficient of Variation 107	244 hours * nanograms/mL Geometric Coefficient of Variation 120	508 hours * nanograms/mL Geometric Coefficient of Variation 96.0	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 1 7-COOH-CBD	297 hours * nanograms/mL Geometric Coefficient of Variation 97.3	125 hours * nanograms/mL Geometric Coefficient of Variation 1750	195 hours * nanograms/mL Geometric Coefficient of Variation 573	—
Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 Day 22 7-COOH-CBD	4190 hours * nanograms/mL Geometric Coefficient of Variation 81.20	9220 hours * nanograms/mL Geometric Coefficient of Variation 178	15500 hours * nanograms/mL Geometric Coefficient of Variation 148	—

SECONDARY outcome

Timeframe: Predose on Days 1 and 22

Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22).

Outcome measures

Outcome measures
Measure	GWP42003-P 5 mg/kg/Day Dose n=6 Participants Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose n=6 Participants Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose n=5 Participants Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo n=5 Participants Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations % change in CLB	-1.2 percent change	18.0 percent change	29.6 percent change	15.1 percent change
Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations % change in N-CLB	258.7 percent change	170.7 percent change	228.9 percent change	-5.6 percent change

Adverse Events

GWP42003-P 5 mg/kg/Day Dose

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

GWP42003-P 10 mg/kg/Day Dose

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

GWP42003-P 20 mg/kg/Day Dose

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GWP42003-P 5 mg/kg/Day Dose n=10 participants at risk Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 10 mg/kg/Day Dose n=8 participants at risk Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	GWP42003-P 20 mg/kg/Day Dose n=9 participants at risk Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.	Placebo n=7 participants at risk Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
General disorders Pyrexia	0.00% 0/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	25.0% 2/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Infections and infestations Parvovirus Infection	0.00% 0/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	11.1% 1/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Infections and infestations Viral Infection	0.00% 0/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	14.3% 1/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Nervous system disorders Convulsion	0.00% 0/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	12.5% 1/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	14.3% 1/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Nervous system disorders Status Epilepticus	10.0% 1/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Skin and subcutaneous tissue disorders Rash Maculo-papular	0.00% 0/10 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	12.5% 1/8 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/9 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.	0.00% 0/7 • Up to Day 60 All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.

Other adverse events

Additional Information

Medical Enquires

GW Research Ltd.

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60