Trial Outcomes & Findings for A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis (NCT NCT01604265)
NCT ID: NCT01604265
Last Updated: 2023-01-10
Results Overview
The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
0 - 4 weeks
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Sativex
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sativex
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Continuous
|
50.30 years
STANDARD_DEVIATION 6.70 • n=93 Participants
|
48.08 years
STANDARD_DEVIATION 9.73 • n=4 Participants
|
49.23 years
STANDARD_DEVIATION 8.32 • n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
34 participants
n=93 Participants
|
32 participants
n=4 Participants
|
66 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)
|
-2.7 units on a scale
Standard Deviation 1.91
|
-1.4 units on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
Each day patients were asked to record in their subject diary, whether or not they were "woken due to nerve pain last night", using a 0-10 Numerical Rating Scale sleep score where zero equated with "did not disrupt sleep" and 10 meant "completely disrupts sleep (unable to sleep due to pain)". A decrease in score from baseline indicates an improvement.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)
|
-2.6 units on a scale
Standard Deviation 2.35
|
-0.8 units on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
A 7-point Likert-type scale was used, with the question: 'Please assess the improvement in overall condition since the start of 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 condition which was used at Week 4 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Outcome measures
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Subject Global Impression of Change at Week 4
Very much improved
|
1 participants
|
0 participants
|
|
Subject Global Impression of Change at Week 4
Much improved
|
8 participants
|
4 participants
|
|
Subject Global Impression of Change at Week 4
Slightly improved
|
15 participants
|
6 participants
|
|
Subject Global Impression of Change at Week 4
No change
|
8 participants
|
19 participants
|
|
Subject Global Impression of Change at Week 4
Slightly worse
|
2 participants
|
3 participants
|
|
Subject Global Impression of Change at Week 4
Much worse
|
0 participants
|
0 participants
|
|
Subject Global Impression of Change at Week 4
Very much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (0 - 4 weeks).Population: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = worst pain imaginable). A negative change from baseline indicates an improvement in pain.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)
|
-15.3 units on a scale
Standard Deviation 13.23
|
-8.1 units on a scale
Standard Deviation 14.60
|
SECONDARY outcome
Timeframe: Baseline to end of study (0 - 4 weeks)Population: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)
|
-0.9 units on a scale
Standard Deviation 10.52
|
5.7 units on a scale
Standard Deviation 10.20
|
SECONDARY outcome
Timeframe: Weeks 0 - 4Population: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=30 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)
|
4.2 units on a scale
Standard Deviation 10.84
|
-1.5 units on a scale
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)
|
1.2 units on a scale
Standard Deviation 6.28
|
3.67 units on a scale
Standard Deviation 4.64
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive performance.
Outcome measures
| Measure |
Sativex
n=30 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=30 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)
|
7.0 percentage of correct answers
Standard Deviation 10.49
|
6.6 percentage of correct answers
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).
Outcome measures
| Measure |
Sativex
n=33 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)
|
5.1 number of words
Standard Deviation 9.49
|
2.9 number of words
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data 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 |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean Total Guy's Neurological Disability Scale Score at the End of Treatment (4 Weeks)
|
-1.5 units on a scale
Standard Deviation 4.45
|
-0.5 units on a scale
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
Intoxication levels were recorded on a Visual Analogue Scale, where zero equated with "no intoxication" and 100 equated with "extreme intoxication". A decrease in baseline score indicates a reduction in intoxication.
Outcome measures
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)
|
3.3 units on a scale
Standard Deviation 9.25
|
0.3 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall depression score at the end of treatment is presented.
Outcome measures
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)
|
-0.1 units on a scale
Standard Deviation 2.92
|
-0.4 units on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall anxiety score at the end of treatment is presented.
Outcome measures
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)
|
-1.0 units on a scale
Standard Deviation 2.06
|
-0.5 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (0 - 4 weeks).Population: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The Multiple Sclerosis Functional Composite test is a three-part, standardized, quantitative, assessment instrument for use in clinical studies. The three components of the test measure leg function/ambulation, arm/hand function, and cognitive function. An increase in score indicates an improvement (range -3 to +3).
Outcome measures
| Measure |
Sativex
n=22 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=21 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)
|
0.25 units on a scale
Standard Deviation 0.364
|
0.19 units on a scale
Standard Deviation 0.174
|
SECONDARY outcome
Timeframe: 0 - 4 weeksPopulation: All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.
The number of patients who experienced an adverse event during the course of the study is presented.
Outcome measures
| Measure |
Sativex
n=34 Participants
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 Participants
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Incidence of Adverse Events as a Measure of Patient Safety.
|
30 participants
|
22 participants
|
Adverse Events
Sativex
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sativex
n=34 participants at risk
Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
|
Placebo
n=32 participants at risk
Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
52.9%
18/34 • All adverse events occurring during the four week 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.
|
15.6%
5/32 • All adverse events occurring during the four week 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%
3/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
|
5.9%
2/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
|
5.9%
2/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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 not otherwise specified
|
2.9%
1/34 • All adverse events occurring during the four week 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.
|
9.4%
3/32 • All adverse events occurring during the four week 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
Dissociation
|
8.8%
3/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
|
5.9%
2/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
|
11.8%
4/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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%
3/34 • All adverse events occurring during the four week 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%
2/32 • All adverse events occurring during the four week 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
Glossodynia
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
9.4%
3/32 • All adverse events occurring during the four week 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
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
9.4%
3/32 • All adverse events occurring during the four week 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
Fall
|
8.8%
3/34 • All adverse events occurring during the four week 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%
2/32 • All adverse events occurring during the four week 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
Weakness
|
5.9%
2/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
|
5.9%
2/34 • All adverse events occurring during the four week 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%
2/32 • All adverse events occurring during the four week 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
Migraine not otherwise specified
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Paraesthesia
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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 not otherwise specified
|
5.9%
2/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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
Dyspepsia
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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 burning
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Chest discomfort
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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 not otherwise specified
|
5.9%
2/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Nasopharyngitis
|
0.00%
0/34 • All adverse events occurring during the four week 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%
2/32 • All adverse events occurring during the four week 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
Otitis media not otherwise specified
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Sinusitis not otherwise specified
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Pharyngitis
|
5.9%
2/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Dyspnoea not otherwise specified
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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
Back pain
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Eye disorders
Diplopia
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Skin and subcutaneous tissue disorders
Rash not otherwise specified
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/34 • All adverse events occurring during the four week 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.
|
3.1%
1/32 • All adverse events occurring during the four week 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.
|
|
Investigations
White blood cell count increased
|
5.9%
2/34 • All adverse events occurring during the four week 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%
0/32 • All adverse events occurring during the four week 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.
Phone: 0044 1223 266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
- Publication restrictions are in place
Restriction type: OTHER