Trial Outcomes & Findings for A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain (NCT NCT01606189)
NCT ID: NCT01606189
Last Updated: 2023-01-10
Results Overview
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Up to 74 days
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
GW-1000-02 First, Then GW-2000-02, Then Placebo
GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-2000-02 First, Then GW-1000-02, Then Placebo
GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
Placebo First, Then GW-1000-02, Then GW-2000-02
Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-1000-02 First, Then Placebo, Then GW-2000-02
GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
Placebo First, Then GW-2000-02, Then GW-1000-02
Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-2000-02 First, Then Placebo, Then GW-1000-02
GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
|---|---|---|---|---|---|---|
|
First Intenvention (14-20 Days)
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
First Intenvention (14-20 Days)
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
First Intenvention (14-20 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intenvention (14-20 Days)
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Second Intenvention (14-20 Days)
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Second Intenvention (14-20 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Intenvention (14-20 Days)
STARTED
|
8
|
8
|
8
|
8
|
8
|
7
|
|
Third Intenvention (14-20 Days)
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
6
|
|
Third Intenvention (14-20 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
GW-1000-02 First, Then GW-2000-02, Then Placebo
GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-2000-02 First, Then GW-1000-02, Then Placebo
GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
Placebo First, Then GW-1000-02, Then GW-2000-02
Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-1000-02 First, Then Placebo, Then GW-2000-02
GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
Placebo First, Then GW-2000-02, Then GW-1000-02
Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
GW-2000-02 First, Then Placebo, Then GW-1000-02
GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).
Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).
|
|---|---|---|---|---|---|---|
|
Second Intenvention (14-20 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Intenvention (14-20 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain
Baseline characteristics by cohort
| Measure |
All Study Treatments: GW-1000-02, GW-2000-02 and Placebo
n=48 Participants
As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.53 years
STANDARD_DEVIATION 10.342 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=45 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=47 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)
|
-0.6 units on a scale
Standard Deviation 1.13
|
-0.6 units on a scale
Standard Deviation 1.34
|
0.0 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as "None", "Once", "Twice" and "More Than Twice" and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=44 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=46 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
|
-0.2 units on a scale
Standard Deviation 0.43
|
-0.4 units on a scale
Standard Deviation 0.51
|
0.0 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero "Worst Imaginable" to 10 "Best Imaginable". The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=45 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=47 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
|
0.9 units on a scale
Standard Deviation 1.22
|
1.2 units on a scale
Standard Deviation 1.39
|
0.4 units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = "None", one = "Mild", two = "Moderate" and three = "Severe". The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)
|
-3.2 units on a scale
Standard Deviation 8.91
|
-3.8 units on a scale
Standard Deviation 9.37
|
-1.8 units on a scale
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero "No pain" to 100 "Worst possible pain". Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)
|
-14.9 units on a scale
Standard Deviation 25.15
|
-17.3 units on a scale
Standard Deviation 26.74
|
-8.0 units on a scale
Standard Deviation 26.92
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as "No Pain", "Mild", "Discomforting", "Distressing", "Horrible" and "Excruciating". The change from baseline in the number of patients who reported "No Pain" or "Mild Pain" at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)
|
4 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with "no disability" and 10 equated with "total disability". The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
|
-5.3 units on a scale
Standard Deviation 9.97
|
-3.1 units on a scale
Standard Deviation 10.37
|
-3.6 units on a scale
Standard Deviation 7.69
|
SECONDARY outcome
Timeframe: Up to 74 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
|
-2.2 units on a scale
Standard Deviation 6.70
|
-1.2 units on a scale
Standard Deviation 6.12
|
0.1 units on a scale
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Up to 114 daysPopulation: All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
The number of patients who experienced an adverse event during the course of study is presented.
Outcome measures
| Measure |
GW-1000-02
n=46 Participants
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 Participants
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
Placebo
n=48 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|---|
|
Incidence of Adverse Events as a Measure of Patient Safety.
|
34 participants
|
37 participants
|
20 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
GW-1000-02
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
GW-2000-02
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=48 participants at risk
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
GW-1000-02
n=46 participants at risk
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 participants at risk
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.2%
1/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
Placebo
n=48 participants at risk
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
GW-1000-02
n=46 participants at risk
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
|
GW-2000-02
n=47 participants at risk
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.3%
4/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
19.6%
9/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
23.4%
11/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
10.4%
5/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
15.2%
7/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
12.8%
6/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
21.7%
10/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
10.6%
5/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Headache Not Otherwise Specified
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
10.6%
5/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
3/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
10.6%
5/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dry Mouth
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.5%
3/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.4%
3/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Oral Discomfort
|
8.3%
4/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling Drunk
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.7%
4/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.5%
4/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Lethargy
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.4%
3/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Pain Exacerbated
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.5%
4/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Thirst
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.4%
3/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.5%
3/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
8.5%
4/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Paresthesia Oral
|
4.2%
2/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Oral Pain
|
4.2%
2/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
4.2%
2/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
4.2%
2/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
Appetite Increased
|
0.00%
0/48 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/46 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
2/47 • All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Additional Information
Mr Richard Potts, Clinical Operations Director
GW Pharma Ltd.
Phone: 0044 1223 266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
- Publication restrictions are in place
Restriction type: OTHER