Trial Outcomes & Findings for A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis (NCT NCT00678795)
NCT ID: NCT00678795
Last Updated: 2023-05-03
Results Overview
To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
0 - 10 weeks
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Sativex
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
56
|
62
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Sativex
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
Baseline Characteristics
A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Sativex
n=67 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=68 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
48.61 years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
46.79 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
47.69 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=60 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=64 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment
|
-1.08 number of daily episodes
Standard Deviation 1.42
|
-0.99 number of daily episodes
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Daily diary entries throughout 10 week study periodPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=60 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=64 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment
|
-1.91 number of daily episodes
Standard Deviation 2.44
|
-1.12 number of daily episodes
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=60 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=64 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment
|
-0.55 number of daily episodes
Standard Deviation 0.75
|
-0.21 number of daily episodes
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=48 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=55 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment
|
-0.88 pads used daily
Standard Deviation 1.50
|
-0.73 pads used daily
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.
Outcome measures
| Measure |
Sativex
n=59 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=61 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)
|
14.21 units on a scale
Standard Deviation 17.51
|
9.58 units on a scale
Standard Deviation 12.77
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = "no problems" and 10 = "intolerable problems". Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=61 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=66 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment
|
-2.3 units on a scale
Standard Deviation 2.16
|
-0.9 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The numbers who scored 1, 2, or 3 are presented.
Outcome measures
| Measure |
Sativex
n=63 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=67 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Patient's Global Impression of Change
|
51 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 0 - 10 weeksPopulation: All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.
Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.
Outcome measures
| Measure |
Sativex
n=60 Participants
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=64 Participants
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Change From Baseline in the Mean Number of Daily Voids at the End of Treatment
|
-1.73 number of daily episodes
Standard Deviation 1.95
|
-0.87 number of daily episodes
Standard Deviation 1.86
|
Adverse Events
Sativex
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sativex
n=67 participants at risk
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=68 participants at risk
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.5%
1/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.5%
1/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.5%
1/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.5%
1/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.5%
1/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
1.5%
1/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Other adverse events
| Measure |
Sativex
n=67 participants at risk
Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
|
Placebo
n=68 participants at risk
Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting Not Otherwise Specified
|
6.0%
4/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.4%
3/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Diarrhoea Not Otherwise Specified
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.9%
4/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling Drunk
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Weakness
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Fatigue
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.4%
3/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Application Site Pain
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.4%
3/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Urinary tract infection Not Otherwise Specified
|
6.0%
4/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
10.3%
7/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Cystitis Not Otherwise Specified
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dizziness
|
17.9%
12/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
7.4%
5/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Headache Not Otherwise Specified
|
7.5%
5/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
7.4%
5/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Balance Impaired Not Otherwise Specified
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
3/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
4.4%
3/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Disorientation
|
6.0%
4/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Dissociation
|
6.0%
4/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Feeling Abnormal
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Chest Pain
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
General disorders
Pyrexia
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Influenza
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Infections and infestations
Pharyngitis Viral Not Otherwise Specified
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Disturbance in Attention
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Memory Impairment
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Somnolence
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
2.9%
2/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Confusion
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Skin and subcutaneous tissue disorders
Sweating Increased
|
3.0%
2/67 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
0.00%
0/68 • All adverse events occurring from the extension study onset to the last study visit (up to 99 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
Additional Information
Mr Richard Potts, Clinical Operations Director
GW Pharma Ltd.
Phone: 0044 1223 266800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
- Publication restrictions are in place
Restriction type: OTHER