Trial Outcomes & Findings for Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) (NCT NCT02953548)
NCT ID: NCT02953548
Last Updated: 2022-09-02
Results Overview
TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
From signing of informed consent up to Day 15
Results posted on
2022-09-02
Participant Flow
Participants were screened to assess their eligibility to enter the trial within 7 days prior to the first dose administration.
Participant milestones
| Measure |
Cohort 1: GWP42003-P OS
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
Baseline characteristics by cohort
| Measure |
GWP42003-P OS
n=9 Participants
Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From signing of informed consent up to Day 15Population: Safety Analysis Set: all participants who received at least 1 dose of GWP42003-P
TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs)
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 4 and Day 15Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Any Low or High Hematology Laboratory Parameter Value
Day 4, Low
|
4 Participants
|
—
|
|
Number of Participants With Any Low or High Hematology Laboratory Parameter Value
Day 4, High
|
4 Participants
|
—
|
|
Number of Participants With Any Low or High Hematology Laboratory Parameter Value
Day 15, Low
|
1 Participants
|
—
|
|
Number of Participants With Any Low or High Hematology Laboratory Parameter Value
Day 15, High
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 4 and Day 15Population: Safety Analysis Set. Only participants with evaluable data were analyzed.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
Day 15, Low
|
5 Participants
|
—
|
|
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
Day 15, High
|
7 Participants
|
—
|
|
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
Day 4, Low
|
7 Participants
|
—
|
|
Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value
Day 4, High
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 4 and Day 15Population: Safety Analysis Set
Clinical relevance was determined by the investigator.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participant With Any Clinically Relevant Urinalysis Parameter Value
Day 4
|
0 Participants
|
—
|
|
Number of Participant With Any Clinically Relevant Urinalysis Parameter Value
Day 15
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From signing of informed consent up to Day 15Population: Safety Analysis Set
Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram Findings
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From signing of informed consent up to Day 15Population: Safety Analysis Set
Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Findings
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From signing of informed consent up to Day 15Population: Safety Analysis Set
Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Findings
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants Free of Clinical Spasms
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Percentage of Participants Free of Clinical Spasms
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants With Resolution of Hypsarrhythmia
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Percentage of Participants With Resolution of Hypsarrhythmia
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 4 and Day 15Population: Safety Analysis Set
Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizures included: clonic, tonic-clonic, myoclonic, focal, and absence.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Not Done
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Clonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Tonic-Clonic
|
1 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Atonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Myoclonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Focal
|
1 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Absence
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 4, Not Done
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Clonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Tonic-Clonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Atonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Myoclonic
|
0 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Focal
|
2 Participants
|
—
|
|
Number of Participants Experiencing Spasms and Seizures by Subtype
Day 15, Absence
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to start of Open-label Extension (OLE) PhasePopulation: Safety Analysis Set
Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase (NCT02954887) for up to 1 year.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Caregiver Clinical Global Impression of Change (CGIC)
Very Much Improved
|
1 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Much Improved
|
0 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Slightly Improved
|
7 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
No Change
|
1 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Slightly Worse
|
0 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Much Worse
|
0 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Very Much Worse
|
0 participants
|
—
|
|
Caregiver Clinical Global Impression of Change (CGIC)
Not Done
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Safety Analysis Set
The PGIC is a single-question assessment completed by the investigator. The question assesses the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=9 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Physician Global Impression of Change (PGIC)
No Change
|
3 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Very Much Improved
|
0 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Much Improved
|
1 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Slightly Improved
|
5 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Slightly Worse
|
0 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Much Worse
|
0 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Very Much Worse
|
0 participants
|
—
|
|
Physician Global Impression of Change (PGIC)
Not Done
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: Safety Analysis Set
A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=5 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
n=4 Participants
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Number of Responders
|
0 responders
|
0 responders
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: Safety Analysis Set
A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Testing for responders was conducted by VEEG for at least 8 hours and up to 24 hours.
Outcome measures
| Measure |
Cohort 1: GWP42003-P OS
n=5 Participants
Participants 6 months to 24 months of age received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 milligrams per kilograms per day (mg/kg/day) of GWP42003-P.
|
Cohort 2: GWP42003-P OS
n=4 Participants
Participants 1 month to 24 months of age received GWP42003-P OS for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|---|
|
Percentage of Responders
|
0 responders
|
0 responders
|
Adverse Events
GWP42003-P OS
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GWP42003-P OS
n=9 participants at risk
Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|
|
Nervous system disorders
Status epilepticus
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
Other adverse events
| Measure |
GWP42003-P OS
n=9 participants at risk
Participants received GWP42003-P oral solution (OS) for 14 days. Starting on Day 1 and over the course of 4 days, participants titrated up to a tolerable dose, not to exceed the target dose of 40 mg/kg/day of GWP42003-P.
|
|---|---|
|
General disorders
Application site erosion
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Psychiatric disorders
Irritability
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Metabolism and nutrition disorders
Increased appetite
|
11.1%
1/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
2/9 • From signing of informed consent up to Day 15
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
|
Additional Information
Medical Enquires
GW Research Ltd
Phone: +44 01223 238170; 1877886281
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60