Trial Outcomes & Findings for A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients (NCT NCT01964547)
NCT ID: NCT01964547
Last Updated: 2023-01-12
Results Overview
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
0-48 weeks
Results posted on
2023-01-12
Participant Flow
Participant milestones
| Measure |
Sativex
Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
59
|
|
Overall Study
COMPLETED
|
50
|
48
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
Sativex
Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Investigator
|
0
|
1
|
Baseline Characteristics
A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Sativex
n=62 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=59 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
Total
n=121 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
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
48.95 years
STANDARD_DEVIATION 8.954 • n=5 Participants
|
48.21 years
STANDARD_DEVIATION 10.381 • n=7 Participants
|
48.59 years
STANDARD_DEVIATION 9.642 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
62 participants
n=5 Participants
|
59 participants
n=7 Participants
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.
Outcome measures
| Measure |
Sativex
n=55 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=52 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.
|
6.8 units on a scale
Standard Deviation 16.16
|
6.8 units on a scale
Standard Deviation 13.49
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.
Outcome measures
| Measure |
Sativex
n=57 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=56 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.
|
-3.1 units on a scale
Standard Deviation 7.76
|
-2.4 units on a scale
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Patients were asked the following question, to be rated on a seven-point scale: "Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below". The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'. The number of patients for each of the markers is presented at the final study visit.
Outcome measures
| Measure |
Sativex
n=58 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=56 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Very Much Better
|
2 participants
|
0 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Much Better
|
16 participants
|
6 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Minimally Better
|
24 participants
|
15 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
No Change
|
13 participants
|
27 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Minimally Worse
|
1 participants
|
7 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Much Worse
|
2 participants
|
1 participants
|
|
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Caregivers were asked the following question to be rated on a seven-point scale: "How has the subject's spasticity changed since Visit 1?" The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit.
Outcome measures
| Measure |
Sativex
n=41 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=40 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Very Much Better
|
1 participants
|
0 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Much Better
|
12 participants
|
6 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Minimally Better
|
14 participants
|
10 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
No Change
|
11 participants
|
18 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Minimally Worse
|
3 participants
|
3 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Much Worse
|
0 participants
|
3 participants
|
|
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Physicians were asked the following question to be rated on a seven-point scale: "How has the subject's spasticity changed since Visit 1?" The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit.
Outcome measures
| Measure |
Sativex
n=58 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=56 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Very Much Better
|
0 participants
|
1 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Much Better
|
15 participants
|
6 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Minimally Better
|
26 participants
|
15 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
No Change
|
14 participants
|
29 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Minimally Worse
|
3 participants
|
4 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Much Worse
|
0 participants
|
1 participants
|
|
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.
Outcome measures
| Measure |
Sativex
n=58 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=56 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.
|
-10.6 units on a scale
Standard Deviation 11.26
|
-7.7 units on a scale
Standard Deviation 10.70
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.
Outcome measures
| Measure |
Sativex
n=58 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=56 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.
|
-0.6 visits
Standard Deviation 0.99
|
-0.4 visits
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: "Wish to be Dead", "Non-specific Active Suicidal Thoughts", "Active Suicidal Ideation Without Intent", "Active Suicidal Ideation With Intent, No Plan", "Active Suicidal Ideation With Intent and Plan". The number of patients with a treatment-emergent flag is presented.
Outcome measures
| Measure |
Sativex
n=62 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=59 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Non-specific Active Suicidal Thoughts
|
0 participants
|
1 participants
|
|
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Wish to be Dead
|
0 participants
|
2 participants
|
|
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Active Suicidal Ideation Without Intent
|
0 participants
|
1 participants
|
|
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Active Suicidal Ideation With Intent, No Plan
|
0 participants
|
0 participants
|
|
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Active Suicidal Ideation With Intent and Plan
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.
Outcome measures
| Measure |
Sativex
n=47 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=50 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Change From Baseline to End of Treatment in Timed 10-meter Walk Times.
|
6.2 seconds
Standard Deviation 55.34
|
3.0 seconds
Standard Deviation 24.68
|
SECONDARY outcome
Timeframe: 0-50 weeksPopulation: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
The number of subjects who experienced an adverse event during the course of the study is presented.
Outcome measures
| Measure |
Sativex
n=62 Participants
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=59 Participants
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Incidence of Adverse Events as a Measure of Patient Safety.
|
39 participants
|
19 participants
|
Adverse Events
Sativex
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sativex
n=62 participants at risk
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=59 participants at risk
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Inguinal Hernia
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Drug Withdrawal Syndrome
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Bronchitis
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Pneumonia
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Overdose
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Tetany
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Nervous system disorders
Dysarthria
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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=62 participants at risk
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
|
Placebo
n=59 participants at risk
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
9.7%
6/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Visual Impairment
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Gingivitis
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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 Mucosal Erythema
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Vomiting
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Asthenia
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
8.1%
5/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Bacterial Infection
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Herpes Zoster
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Subcutaneous Abscess
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Tonsillitis
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Upper Respiratory Tract Infection
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
5.1%
3/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Upper Respiratory Tract Infection Bacterial
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
8.1%
5/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Viral Infection
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Contusion
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Face Injury
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Foot Fracture
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Forearm Fracture
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Joint Dislocation
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Lower Limb Fracture
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Procedural Vomiting
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Thermal Burn
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Upper Limb Fracture
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Blood Alkaline Phosphatase Increased
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Vitamin D Decreased
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Weight Decreased
|
4.8%
3/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Decreased Appetite
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Cerebellar Ataxia
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Cognitive Disorder
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
8.1%
5/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
4.8%
3/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
6.8%
4/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Muscle Spasticity
|
8.1%
5/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
3.4%
2/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Neuralgia
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Paraparesis
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Radiculopathy
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Stupor
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Tremor
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Trigeminal Neuralgia
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Anxiety Disorder Due To A General Medical Condition
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Psychiatric disorders
Euphoric Mood
|
3.2%
2/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Suicidal Ideation
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Erectile Dysfunction
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Oropharyngeal Blistering
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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
Dermatitis Allergic
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Surgical and medical procedures
Lipoma Excision
|
0.00%
0/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
1.7%
1/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
|
|
Surgical and medical procedures
Tooth Extraction
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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 Discomfort
|
1.6%
1/62 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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%
0/59 • All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were 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 Pharma Ltd (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