Trial Outcomes & Findings for An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (NCT NCT02564952)
NCT ID: NCT02564952
Last Updated: 2022-09-28
Results Overview
An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
Results posted on
2022-09-28
Participant Flow
All participants were enrolled by invitation into the open-label extension (OLE) phase after completing the double-blind phase of the study.
Two of the 18 participants withdrew during the OLE titration period: 1 met protocol-specified withdrawal criteria; 1 had GWP42003-P withdrawn due to adverse events (AEs) ongoing at entry to the OLE phase.
Participant milestones
| Measure |
GWP42003-P
Participants who transferred from the double blind (DB) phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
Clobazam (CLB) was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
18
|
|
Overall Study
Completed OLE Titration Period
|
16
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
GWP42003-P
Participants who transferred from the double blind (DB) phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
Clobazam (CLB) was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Participant Withdrawn by Investigator
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Low Efficacy
|
1
|
|
Overall Study
Participant Met Withdrawal Criteria
|
1
|
Baseline Characteristics
An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Baseline characteristics by cohort
| Measure |
GWP42003-P
n=18 Participants
Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
CLB was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Age, Continuous
|
36.35 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Any History Of Current Seizures
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)Population: The OLE population included all participants who completed the double-blind phase and entered the OLE phase of the study. The OLE population was the primary analysis set for all safety endpoints reported.
An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. 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
n=18 Participants
Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
CLB was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Number Of Participants Who Experienced Severe OLE-Emergent AEs
|
4 Participants
|
Adverse Events
GWP42003-P
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GWP42003-P
n=18 participants at risk
Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
CLB was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Investigations
Alanine aminotransferase abnormal
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Aspartate aminotransferase abnormal
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Status epilepticus
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
Other adverse events
| Measure |
GWP42003-P
n=18 participants at risk
Participants who transferred from the DB phase (NCT02565108) to the OLE (still blinded at that stage) tapered off their GWP42003-P or placebo treatment by reducing their maintenance dose by 10% per day and concomitantly titrating GWP42003-P to 20 mg/kg/day initially for the OLE; doses could then be adjusted up or down, dependent on investigator opinion, to a maximum of 30 mg/kg/day GWP42003-P.
CLB was administered in line with the physician's preferred CLB dosing regimen for each participant.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
8/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
General disorders
Fatigue
|
11.1%
2/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
General disorders
Gait disturbance
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
2/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Cystitis
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Eczema infected
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Infected bite
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Tonsillitis
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Eosinophil count increased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Investigations
White blood cell count decreased
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
2/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Somnolence
|
38.9%
7/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Dizziness
|
22.2%
4/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Seizure
|
11.1%
2/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Dysarthria
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Nervous system disorders
Sedation
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Irritability
|
11.1%
2/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Abnormal behaviour
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Affect lability
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Hallucination, visual
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Panic attack
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Psychiatric disorders
Tearfulness
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.6%
1/18 • Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)
The number of participants who experienced OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 \[± 3\] days following the last dose of IMP) is presented. The OLE population was the primary analysis set for all safety endpoints reported. Participants' expected seizure types were not routinely documented as AEs. However, any worsening, including change in the pattern or severity of seizures, was documented as an AE.
|
Additional Information
Medical Enquiries
GW Research Ltd
Phone: +44 01223 238170; +18778862810
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60