Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS) (NCT NCT00681538)
NCT ID: NCT00681538
Last Updated: 2023-05-06
Results Overview
Subjects were asked "On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours" with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. They were asked to relate 'no spasticity' to the time prior to the onset of their spasticity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
572 participants
Primary outcome timeframe
Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)
Results posted on
2023-05-06
Participant Flow
Only those subjects who were deemed responders to Sativex from Phase A (i.e. at least a 20% reduction in mean 0-10 point numerical rating scale (NRS) spasticity score between screening and the end of the four week Phase A treatment) were eligible to enter Phase B of the study.
Participant milestones
| Measure |
Sativex (Phase B)
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Phase A- 4 Weeks Single Blind
STARTED
|
572
|
0
|
|
Phase A- 4 Weeks Single Blind
COMPLETED
|
538
|
0
|
|
Phase A- 4 Weeks Single Blind
NOT COMPLETED
|
34
|
0
|
|
Phase B- Responders;12 Week Double-blind
STARTED
|
124
|
117
|
|
Phase B- Responders;12 Week Double-blind
COMPLETED
|
109
|
115
|
|
Phase B- Responders;12 Week Double-blind
NOT COMPLETED
|
15
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 Years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
48.1 Years
STANDARD_DEVIATION 9.59 • n=7 Participants
|
48.6 Years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Duration of Multiple Sclerosis Phase B
|
13.3 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
11.8 years
STANDARD_DEVIATION 7.38 • n=7 Participants
|
12.6 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
|
Duration of Spasticity Phase B
|
8.6 years
STANDARD_DEVIATION 6.89 • n=5 Participants
|
6.7 years
STANDARD_DEVIATION 5.40 • n=7 Participants
|
7.7 years
STANDARD_DEVIATION 6.27 • n=5 Participants
|
|
Expanded Disability Status Scale (EDSS)- Phase B
|
6.5 Score
STANDARD_DEVIATION 1.46 • n=5 Participants
|
6.0 Score
STANDARD_DEVIATION 1.44 • n=7 Participants
|
6.0 Score
STANDARD_DEVIATION 1.45 • n=5 Participants
|
|
Baseline Spasticity numerical rating scale (NRS) Score Phase B
|
3.87 Score
STANDARD_DEVIATION 1.49 • n=5 Participants
|
3.92 Score
STANDARD_DEVIATION 1.55 • n=7 Participants
|
3.90 Score
STANDARD_DEVIATION 1.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)Subjects were asked "On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours" with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. They were asked to relate 'no spasticity' to the time prior to the onset of their spasticity.
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).
|
3.68 Points on scale
Standard Deviation 1.83
|
4.56 Points on scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline (Day 1) - End of treatment (last 7 days of Week 17)A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders.
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.
30% improvement in spasticity
|
92 participants
|
60 participants
|
|
Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.
50% improvement in spasticity
|
56 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)The subjects' baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).
|
5.56 Spasms per day
Standard Deviation 10.33
|
7.70 Spasms per day
Standard Deviation 12.02
|
SECONDARY outcome
Timeframe: Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked "On a scale of '0 to 10' please indicate how you your spasticity disrupted your sleep last night" with the anchors: 0 = 'did not disrupt sleep' and 10 = 'completely disrupted (unable to sleep at all)'.
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).
|
1.71 Points on scale
Standard Deviation 1.65
|
2.65 Points on scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline (End of Week 4) - End of treatment (End of Week 17)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.
Outcome measures
| Measure |
Sativex (Phase B)
n=121 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=116 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).
|
-0.1 Score on scale
Standard Deviation 8.25
|
1.8 Score on scale
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Baseline (End of Week 4) - End of treatment (End of Week 17)Population: For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.
Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.
Leg
|
-1.3 Score on scale
Standard Deviation 7.64
|
-1.0 Score on scale
Standard Deviation 9.48
|
|
Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.
Arm
|
0.5 Score on scale
Standard Deviation 15.62
|
0.8 Score on scale
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Baseline (End of Week 4) - End of treatment (End of Week 17)Population: Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.
Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.
Outcome measures
| Measure |
Sativex (Phase B)
n=84 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=83 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).
|
-2.3 Seconds
Standard Deviation 8.38
|
2.0 Seconds
Standard Deviation 15.16
|
SECONDARY outcome
Timeframe: End of Treatment (WeeK 17)Outcome measures
| Measure |
Sativex (Phase B)
n=121 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Very much better
|
14 participants
|
10 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Much better
|
40 participants
|
28 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Minimally better
|
39 participants
|
33 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
No change
|
17 participants
|
35 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Minimally worse
|
4 participants
|
7 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Much worse
|
6 participants
|
1 participants
|
|
Subject Global Impressions of Change at End of Treatment (Phase B).
Very much worse
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: End of treatment (Week 17)Population: Sample sizes were reduced as not all subjects had a Carer to make this assessment.
Outcome measures
| Measure |
Sativex (Phase B)
n=71 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=69 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Very much better
|
2 participants
|
0 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Much better
|
15 participants
|
11 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Minimally better
|
31 participants
|
19 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
No change
|
16 participants
|
24 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Minimally worse
|
4 participants
|
8 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Much worse
|
2 participants
|
5 participants
|
|
Carer Global Impressions of Change at of Treatment (Phase B).
Very much worse
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: End of treatment (week 17)Population: Sample sizes were reduced as not all subjects had a Carer to make this assessment.
Outcome measures
| Measure |
Sativex (Phase B)
n=71 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=69 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Very much better
|
1 participants
|
1 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Much better
|
9 participants
|
8 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Minimally better
|
27 participants
|
14 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
No change
|
24 participants
|
30 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Minimally worse
|
6 participants
|
11 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Much worse
|
4 participants
|
3 participants
|
|
Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).
Very much worse
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: End of treatment (week 17)Outcome measures
| Measure |
Sativex (Phase B)
n=122 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Very much better
|
6 participants
|
8 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Much better
|
44 participants
|
29 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Minimally better
|
45 participants
|
26 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
No change
|
17 participants
|
37 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Minimally worse
|
4 participants
|
13 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Much worse
|
6 participants
|
4 participants
|
|
Physician Global Impressions of Change at End of Treatment (Phase B).
Very much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: [Baseline (End of Week 4) - End of treatment (End of Week 17)Population: EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.
The EQ-5D questionnaire provided two outcomes: 1. A weighted health state index visual analogue scale (VAS) 2. A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Outcome measures
| Measure |
Sativex (Phase B)
n=124 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)
EQ-5D Health State Index
|
0.003 score on scale
Standard Deviation 0.155
|
-0.013 score on scale
Standard Deviation 0.176
|
|
Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)
EQ-5D Health Status VAS
|
-0.7 score on scale
Standard Deviation 15.3
|
-2.8 score on scale
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Baseline (End of week 4) - end of treatment (end of week 17)This was a 21-question multiple choice self-report inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.
Outcome measures
| Measure |
Sativex (Phase B)
n=114 Participants
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=113 Participants
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)
|
0.5 Score on scale
Standard Deviation 5.01
|
0.4 Score on scale
Standard Deviation 6.54
|
Adverse Events
Sativex (Phase B)
Serious events: 6 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo (Phase B)
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sativex (Phase B)
n=124 participants at risk
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 participants at risk
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Septic shock
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Urosepsis
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
MS Relapse
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.81%
1/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
Sativex (Phase B)
n=124 participants at risk
contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
|
Placebo (Phase B)
n=117 participants at risk
Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
7.3%
9/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
10.3%
12/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
2.6%
3/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs 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
|
5.6%
7/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
6.8%
8/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
5/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
4/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs 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 extremity
|
0.00%
0/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
5/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Headache
|
1.6%
2/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
4.3%
5/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Muscle spasticity
|
2.4%
3/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
4/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dizziness
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
MS relapse
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
3/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
6/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
5/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
2/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
4.8%
6/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Euphoric mood
|
3.2%
4/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
7/124 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
0.85%
1/117 • All AEs occurring from Baseline(week 4) to end of treatment (Week 17) (Phase B) i.e. 13 weeks were collected. All deaths and SAEs occurring within 28 days of the final dose of study medication were also collected.
All AEs occurring during the study were reported on the running logs at the back of the study case report form.
|
Additional Information
Richard Potts, Clinical Operations Director
GW Pharma Ltd
Phone: +44 1353 616600
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