Trial Outcomes & Findings for An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients (NCT NCT01610700)
NCT ID: NCT01610700
Last Updated: 2023-01-12
Results Overview
This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.
COMPLETED
PHASE3
160 participants
baseline and 6 weeks
2023-01-12
Participant Flow
Participant milestones
| Measure |
GW-1000-02
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
GW-1000-02
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
subject took one dose of street cannabis
|
0
|
1
|
Baseline Characteristics
An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
GW-1000-02
n=80 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=80 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
50.96 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
50.42 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
50.69 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-25.32 units on a scale
Standard Deviation 23.42
|
-19.32 units on a scale
Standard Deviation 27.02
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=71 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=65 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-23.44 units on a scale
Standard Deviation 21.59
|
-15.98 units on a scale
Standard Deviation 23.46
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=39 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 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 Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-15.62 units on a scale
Standard Deviation 21.76
|
-13.06 units on a scale
Standard Deviation 29.52
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=51 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=56 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-24.15 units on a scale
Standard Deviation 20.99
|
-21.04 units on a scale
Standard Deviation 25.08
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=25 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=25 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-21.40 units on a scale
Standard Deviation 24.41
|
-15.70 units on a scale
Standard Deviation 25.44
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.
Outcome measures
| Measure |
GW-1000-02
n=55 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=57 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment
|
-28.10 units on a scale
Standard Deviation 25.87
|
-21.61 units on a scale
Standard Deviation 25.61
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your multiple sclerosis since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their Multiple sclerosis which was used at end of treatment to aid their memory regarding their symptoms at study start. The number of subjects that considered their condition to be better or much better at the end of treatment is presented.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Subject Global Opinion of Effect on Multiple Sclerosis at the End of Treatment
|
32 participants
|
21 participants
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=73 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=70 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in Modified Ashworth Scale Score at the End of Treatment
|
-0.38 units on a scale
Standard Deviation 2.51
|
-0.58 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
This was a 21-question multiple choice self-report inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=78 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Beck's Depression Inventory (BDI-II) Score at the End of Treatment
|
-2.1 units on a scale
Standard Deviation 5.59
|
-2.9 units on a scale
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=78 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=76 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Fatigue Severity Scale Questionnaire Score at the End of Treatment
|
-0.30 units on a scale
Standard Deviation 1.14
|
-0.09 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Rivermead Mobility Index Score at the End of Treatment
|
0.2 units on a scale
Standard Deviation 1.68
|
-0.0 units on a scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 \[good\] to 21 \[bad\]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=75 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Total 28-item General Health Questionnaire Score at the End of Treatment
|
-1.7 units on a scale
Standard Deviation 11.58
|
-3.0 units on a scale
Standard Deviation 9.68
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=66 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=65 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Nine-hole Peg Test Score at the End of Treatment
|
-0.47 units on a scale
Standard Deviation 3.91
|
0.38 units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The total bladder control test score was the sum score from fifteen questions were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.
Outcome measures
| Measure |
GW-1000-02
n=58 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=60 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Total Bladder Control Test Score at the End of Treatment
|
-2.2 units on a scale
Standard Deviation 4.63
|
-1.7 units on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.
Outcome measures
| Measure |
GW-1000-02
n=40 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=40 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Tremor Activities of Daily Living Scale Score at the End of Treatment
|
-2.2 units on a scale
Standard Deviation 6.53
|
-1.2 units on a scale
Standard Deviation 8.25
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The 10 Metre Mobility Score is a four point scale assessing a subject's level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates an improvement in condition.
Outcome measures
| Measure |
GW-1000-02
n=38 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 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 Ten-metre Mobility Score at the End of Treatment
|
-2.78 time (seconds)
Standard Deviation 4.75
|
-0.74 time (seconds)
Standard Deviation 7.85
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 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 Quality 100 mm Visual Analogue Scale Score at the End of Treatment
|
-16.25 units on a scale
Standard Deviation 27.96
|
-10.05 units on a scale
Standard Deviation 28.04
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 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 Amount 100 mm Visual Analogue Scale Score at the End of Treatment
|
-13.55 units on a scale
Standard Deviation 25.70
|
-9.79 units on a scale
Standard Deviation 26.18
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=79 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Treatment
|
-8.75 units on a scale
Standard Deviation 28.91
|
-9.04 units on a scale
Standard Deviation 25.90
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The ability to undertake the 10 different daily activities was assessed on scales of 0-1, 0-2 or 0-3, with 0 indicative of the poorest outcome and the highest possible score indicative of the best outcome. The summary parameter was the total score for each of the ten items, with a minimum possible score of 0 and a maximum possible score of 20. An increased score indicates an improvement, with a change of two or greater in the total score indicating a clinically relevant change. A positive value therefore indicates an improvement from baseline.
Outcome measures
| Measure |
GW-1000-02
n=78 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=77 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Barthel Activities for Daily Living Scale Score at the End of Treatment
|
-0.4 units on a scale
Standard Deviation 1.81
|
0.1 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered 'normal'. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=78 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=76 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Short Orientation-Memory-Concentration Test at the End of Treatment
|
-1.0 units on a scale
Standard Deviation 5.02
|
0.0 units on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.
Outcome measures
| Measure |
GW-1000-02
n=75 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=72 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Reading Visual Acuity Test Score at the End of Treatment
|
0.1 units on a scale
Standard Deviation 1.99
|
-0.0 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.
Outcome measures
| Measure |
GW-1000-02
n=25 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=18 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Care-Giver Strain Index Score at the End of Treatment
|
-0.9 units on a scale
Standard Deviation 2.53
|
-0.1 units on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=66 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=63 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Guy's Neurological Disability Scale Score at the End of Treatment
|
-0.9 units on a scale
Standard Deviation 6.20
|
-2.7 units on a scale
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.
The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.
Outcome measures
| Measure |
GW-1000-02
n=73 Participants
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=70 Participants
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Total Adult Memory and Information Processing Battery Test Score at the End of Treatment
|
1.8 units on a scale
Standard Deviation 5.15
|
2.1 units on a scale
Standard Deviation 5.51
|
Adverse Events
GW-1000-02
Placebo
Serious adverse events
| Measure |
GW-1000-02
n=80 participants at risk
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=80 participants at risk
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION NOT OTHERWISE SPECIFIED (NOS)
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION NOT OTHERWISE SPECIFIED
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Infections and infestations
SEPSIS NOS
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Infections and infestations
URINARY TRACT INFECTION NOS
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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
RESPIRATORY DISTRESS
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
APPENDICITIS
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS NOS
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
1.2%
1/80 • All adverse events occurring during the six-week parallel group treatment period 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 |
GW-1000-02
n=80 participants at risk
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
|
Placebo
n=80 participants at risk
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
31.2%
25/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
12.5%
10/80 • All adverse events occurring during the six-week parallel group treatment period 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
Disturbance in attention
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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 NOS
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
16.2%
13/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
10.0%
8/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
5.0%
4/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
6.2%
5/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
8.8%
7/80 • All adverse events occurring during the six-week parallel group treatment period 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
Diarrhoea NOS
|
7.5%
6/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
Mouth Ulceration
|
5.0%
4/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
15.0%
12/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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
Application site pain
|
10.0%
8/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
10.0%
8/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
5.0%
4/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
Disorientation
|
7.5%
6/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
5/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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
Application Site Reaction Not Otherwise Specified
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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
Dry Mouth
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Not Otherwise Specified
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Limb
|
0.00%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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
Cough
|
3.8%
3/80 • All adverse events occurring during the six-week parallel group treatment period 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%
0/80 • All adverse events occurring during the six-week parallel group treatment period 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.
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