Trial Outcomes & Findings for A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (NCT NCT02565108)
NCT ID: NCT02565108
Last Updated: 2022-09-28
Results Overview
The Cmax of CLB and its primary metabolite N-desmethylclobazam (N-CLB) was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h. One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33
Results posted on
2022-09-28
Participant Flow
Participant milestones
| Measure |
GWP42003-P 20 mg/kg/Day Dose
Participants received GWP42003-P 20 milligrams (mg)/kilogram (kg)/day orally, twice daily immediately after their clobazam (CLB) dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the open-label extension (OLE) or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an Investigational Medicinal Product (IMP), for the duration of this study.
|
Placebo
Participants received placebo (0 mg/milliliter \[mL\] GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
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|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
|
Overall Study
Safety Set
|
16
|
4
|
|
Overall Study
Pharmacokinetic (PK) Set
|
10
|
3
|
|
Overall Study
COMPLETED
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
GWP42003-P 20 mg/kg/Day Dose
Participants received GWP42003-P 20 milligrams (mg)/kilogram (kg)/day orally, twice daily immediately after their clobazam (CLB) dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the open-label extension (OLE) or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an Investigational Medicinal Product (IMP), for the duration of this study.
|
Placebo
Participants received placebo (0 mg/milliliter \[mL\] GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
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|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
Baseline Characteristics
A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Baseline characteristics by cohort
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=16 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=4 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.60 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
37.57 years
STANDARD_DEVIATION 10.67 • n=7 Participants
|
36.79 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33Population: PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.
The Cmax of CLB and its primary metabolite N-desmethylclobazam (N-CLB) was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h. One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=10 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=3 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: CLB Day 1
|
330 ng/mL
Geometric Coefficient of Variation 40.4
|
440 ng/mL
Geometric Coefficient of Variation 29.9
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: CLB Day 33
|
329 ng/mL
Geometric Coefficient of Variation 54.8
|
461 ng/mL
Geometric Coefficient of Variation 102.3
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: N-CLB Day 1
|
2060 ng/mL
Geometric Coefficient of Variation 138.4
|
1130 ng/mL
Geometric Coefficient of Variation 82.1
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: N-CLB Day 33
|
4570 ng/mL
Geometric Coefficient of Variation 54.0
|
1320 ng/mL
Geometric Coefficient of Variation 134.1
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: CLB Dose-normalized Day 1
|
19.3 ng/mL
Geometric Coefficient of Variation 31.4
|
22.0 ng/mL
Geometric Coefficient of Variation 29.9
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: CLB Dose-normalized Day 33
|
19.2 ng/mL
Geometric Coefficient of Variation 44.7
|
23.1 ng/mL
Geometric Coefficient of Variation 102.3
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: N-CLB Dose-normalized Day 1
|
121 ng/mL
Geometric Coefficient of Variation 125.1
|
56.6 ng/mL
Geometric Coefficient of Variation 82.1
|
|
Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
Cmax: N-CLB Dose-normalized Day 33
|
267 ng/mL
Geometric Coefficient of Variation 38.6
|
66.1 ng/mL
Geometric Coefficient of Variation 134.1
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33Population: PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.
The tmax of CLB and its primary metabolite N-CLB was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h. One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=10 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=3 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
tmax: CLB Day 1
|
1.00 h
Interval 0.8 to 4.0
|
1.17 h
Interval 1.0 to 1.5
|
|
PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
tmax: CLB Day 33
|
1.86 h
Interval 0.5 to 4.0
|
1.58 h
Interval 1.5 to 2.0
|
|
PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
tmax: N-CLB Day 1
|
1.50 h
Interval 0.3 to 6.0
|
2.00 h
Interval 0.0 to 12.0
|
|
PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
tmax: N-CLB Day 33
|
3.03 h
Interval 0.0 to 11.1
|
1.00 h
Interval 0.3 to 2.0
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33Population: PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.
The AUCtau of CLB and its primary metabolite N-CLB was measured on Day 1 (before first GWP42003-P dose; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h. One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=10 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=3 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: CLB Day 1
|
2690 h*ng/mL
Geometric Coefficient of Variation 52.9
|
3320 h*ng/mL
Geometric Coefficient of Variation 67.5
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: CLB Day 33
|
2840 h*ng/mL
Geometric Coefficient of Variation 46.2
|
3310 h*ng/mL
Geometric Coefficient of Variation 102.5
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: N-CLB Day 1
|
18300 h*ng/mL
Geometric Coefficient of Variation 124.2
|
11400 h*ng/mL
Geometric Coefficient of Variation 63.7
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: N-CLB Day 33
|
48400 h*ng/mL
Geometric Coefficient of Variation 53.9
|
11500 h*ng/mL
Geometric Coefficient of Variation 79.1
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: CLB Dose-normalized Day 1
|
157 h*ng/mL
Geometric Coefficient of Variation 47.1
|
166 h*ng/mL
Geometric Coefficient of Variation 67.5
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: CLB Dose-normalized Day 33
|
166 h*ng/mL
Geometric Coefficient of Variation 34.7
|
165 h*ng/mL
Geometric Coefficient of Variation 102.5
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: N-CLB Dose-normalized Day 1
|
1070 h*ng/mL
Geometric Coefficient of Variation 105.1
|
571 h*ng/mL
Geometric Coefficient of Variation 63.7
|
|
PK: Area Under The Plasma Concentration-Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33
AUCtau: N-CLB Dose-normalized Day 33
|
2830 h*ng/mL
Geometric Coefficient of Variation 38.3
|
573 h*ng/mL
Geometric Coefficient of Variation 79.1
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33Population: PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.
The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for Cmax to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% confidence interval (CI) approach for the between time point ratios of geometric means of Cmax was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=10 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=3 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1
Geometric Mean Ratio of CLB, Cmax
|
0.997 Ratio
Interval 0.834 to 1.19
|
1.05 Ratio
Interval 0.401 to 2.74
|
|
PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1
Geometric Mean Ratio of N-CLB, Cmax
|
2.22 Ratio
Interval 1.42 to 3.46
|
1.17 Ratio
Interval 0.628 to 2.17
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33Population: PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.
The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for AUCtau to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% CI approach for the between time point ratios of geometric means of AUCtau was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=10 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=3 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1
Geometric Mean Ratio of CLB, AUCtau
|
1.06 Ratio
Interval 0.898 to 1.24
|
0.996 Ratio
Interval 0.652 to 1.52
|
|
PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1
Geometric Mean Ratio of N-CLB, AUCtau
|
2.64 Ratio
Interval 1.95 to 3.58
|
1.00 Ratio
Interval 0.795 to 1.27
|
SECONDARY outcome
Timeframe: Postdose on Day 2 up to Safety follow-up (Day 71)Population: Safety Set: all participants who received at least 1 dose of IMP (GWP42003-P or placebo). Participants were analyzed according to the treatment they received.
A TEAE was defined as an adverse event with an onset date on or after the first dose of IMP. If an adverse event (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 1 or more severe TEAEs after screening up to Day 71. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=16 Participants
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=4 Participants
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)
|
1 Participants
|
0 Participants
|
Adverse Events
GWP42003-P 20 mg/kg/Day Dose
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=16 participants at risk
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=4 participants at risk
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
Nervous system disorders
Seizure cluster
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
Other adverse events
| Measure |
GWP42003-P 20 mg/kg/Day Dose
n=16 participants at risk
Participants received GWP42003-P 20 mg/kg/day orally, twice daily immediately after their CLB dose. Participants titrated GWP42003-P to 20 mg/kg/day over 10 days and remained at this dose for the 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their GWP42003-P treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
Placebo
n=4 participants at risk
Participants received placebo (0 mg/mL GWP42003-P) orally, twice daily immediately after the participant's CLB dose. Participants titrated the placebo dose over 10 days, followed by a 21-day treatment period. Participants who then did not enter the OLE or withdrew early had a 10-day taper (10% per day) period. Participants who transferred to the OLE (still blinded at that stage) tapered off their placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P for the OLE.
All participants (in the GWP42003-P and Placebo treatment groups) were on a stable dose of CLB at Baseline, administered either once or twice daily as per the physician's preferred CLB dosing regimen for each participant, and continued taking CLB, as an IMP, for the duration of this study.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
6/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
25.0%
1/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Sedation
|
12.5%
2/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Somnolence
|
12.5%
2/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Aphasia
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Hypersomnia
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Memory impairment
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Speech disorder
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
2/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
General disorders
Feeling cold
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Investigations
Liver function test abnormal
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Psychiatric disorders
Abnormal dreams
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Psychiatric disorders
Nervousness
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Psychiatric disorders
Tearfulness
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
12.5%
1/8 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/2 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
25.0%
1/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Nervous system disorders
Dizziness postural
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
0.00%
0/4 • Following screening up to Day 71
The safety analysis set included all participants randomized to treatment who received at least 1 dose of IMP. Participant data were analyzed according to the treatment they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60