Trial Outcomes & Findings for Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis (NCT NCT04657666)
NCT ID: NCT04657666
Last Updated: 2023-07-20
Results Overview
LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
Results posted on
2023-07-20
Participant Flow
A total of 68 participants who met all inclusion and no exclusion criteria were randomized to treatment at 9 clinic centers in Poland and 1 center in Czech Republic.
Randomized participants completed 2 treatment periods with administration of study drug for 21 days per period. A washout period of at least 7 days separated the 2 treatment periods. During the washout period, participants continued their current MS anti-spasticity medications. Each treatment period included a dose titration phase (\~14 days) followed by a maintenance-dose phase (\~7 days), where the optimized dose level remained unchanged for the remainder of the period after titration.
Participant milestones
| Measure |
Nabiximols First, Then Placebo
Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).
|
Placebo First, Then Nabiximols
Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray in the morning and evening for 21 days (starting on Day 31; Treatment Period 2).
|
|---|---|---|
|
Period 1
STARTED
|
33
|
35
|
|
Period 1
COMPLETED
|
30
|
33
|
|
Period 1
NOT COMPLETED
|
3
|
2
|
|
Period 2
STARTED
|
30
|
33
|
|
Period 2
COMPLETED
|
28
|
30
|
|
Period 2
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Nabiximols First, Then Placebo
Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).
|
Placebo First, Then Nabiximols
Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray in the morning and evening for 21 days (starting on Day 31; Treatment Period 2).
|
|---|---|---|
|
Period 1
Withdrawal of participant consent
|
2
|
1
|
|
Period 1
Withdrawn/discontinued due to AE
|
1
|
0
|
|
Period 1
Administrative decision by investigator, GW, or a regulatory authority
|
0
|
1
|
|
Period 2
Other
|
2
|
0
|
|
Period 2
Withdrawn/discontinued due to AE
|
0
|
3
|
Baseline Characteristics
Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Nabiximols First, Then Placebo
n=33 Participants
Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).
|
Placebo First, Then Nabiximols
n=35 Participants
Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray in the morning and evening for 21 days (starting on Day 31; Treatment Period 2).
|
Total
n=68 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
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: LLMT-6 was assessed in the Full Analysis Set.
LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.
Outcome measures
| Measure |
Nabiximols
n=68 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=68 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)
|
-0.23 units on a scale
Standard Error 0.07
|
-0.26 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: LLMT-4 was assessed in the Full Analysis Set.
LLMT-4 is defined as the average of the 4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-4 score is being reported. Negative values indicate an improvement in muscle tone.
Outcome measures
| Measure |
Nabiximols
n=68 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=68 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)
|
-0.23 units on a scale
Standard Error 0.08
|
-0.28 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Safety events were assessed in the Safety Analysis Set.
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
Outcome measures
| Measure |
Nabiximols
n=66 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=65 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
|
27 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Vital signs were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=62 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=61 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Blood Pressure
Systolic blood pressure
|
-3.7 mmHg
Standard Deviation 10.48
|
-2.7 mmHg
Standard Deviation 10.85
|
|
Change From Baseline in Blood Pressure
Diastolic blood pressure
|
-3.6 mmHg
Standard Deviation 9.06
|
-1.7 mmHg
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Electrocardiogram parameters were assessed in the Safety Analysis Set.
Outcome measures
| Measure |
Nabiximols
n=62 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=61 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Heart Rate
|
-2.9 beats/minute
Standard Deviation 8.12
|
2.0 beats/minute
Standard Deviation 9.68
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Physical exam parameters were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Weight
|
0.28 kg
Standard Deviation 1.73
|
0.56 kg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Physical exam parameters were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Body Mass Index
|
0.09 kg/m^2
Standard Deviation 0.67
|
0.19 kg/m^2
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Clinical Laboratory Test Values
Leukocytes
|
-0.144 10^9 cells per liter
Standard Deviation 1.57
|
-0.324 10^9 cells per liter
Standard Deviation 1.08
|
|
Change From Baseline in Clinical Laboratory Test Values
Neutrophils
|
0.015 10^9 cells per liter
Standard Deviation 1.57
|
-0.316 10^9 cells per liter
Standard Deviation 0.99
|
|
Change From Baseline in Clinical Laboratory Test Values
Basophils
|
-0.001 10^9 cells per liter
Standard Deviation 0.04
|
0.000 10^9 cells per liter
Standard Deviation 0.03
|
|
Change From Baseline in Clinical Laboratory Test Values
Eosinophils
|
0.010 10^9 cells per liter
Standard Deviation 0.08
|
0.011 10^9 cells per liter
Standard Deviation 0.08
|
|
Change From Baseline in Clinical Laboratory Test Values
Lymphocytes
|
-0.172 10^9 cells per liter
Standard Deviation 0.33
|
-0.013 10^9 cells per liter
Standard Deviation 0.31
|
|
Change From Baseline in Clinical Laboratory Test Values
Monocytes
|
-0.003 10^9 cells per liter
Standard Deviation 0.16
|
-0.009 10^9 cells per liter
Standard Deviation 0.15
|
|
Change From Baseline in Clinical Laboratory Test Values
Platelets
|
1.0 10^9 cells per liter
Standard Deviation 40.58
|
1.7 10^9 cells per liter
Standard Deviation 35.62
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Erythrocytes
|
-0.101 10^12 cells per liter
Standard Deviation 0.27
|
-0.017 10^12 cells per liter
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Hemoglobin
|
-0.22 g/dL
Standard Deviation 0.79
|
-0.03 g/dL
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Hematocrit was measured in whole blood samples. The ratio of packed cells to total volume was assessed. Normal ratio ranges from 0.350-0.470 female and 0.400-0.540 male (normal ranges per our central lab), 0.37 (or 37%) to 0.52 (or 52%) in adults. Lower hematocrit ratios indicate worse clinical outcome.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Hematocrit Ratio
|
-0.006 ratio of packed cells to total volume
Standard Deviation 0.03
|
-0.001 ratio of packed cells to total volume
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume
|
0.64 fL
Standard Deviation 3.33
|
0.17 fL
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Clinical laboratory tests were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=59 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
|
0.14 pg
Standard Deviation 0.97
|
0.04 pg
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Electrocardiogram parameters were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=62 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=61 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Electrocardiogram Parameters
PR interval
|
11.4 msec
Standard Deviation 102.54
|
-1.7 msec
Standard Deviation 24.79
|
|
Change From Baseline in Electrocardiogram Parameters
QRS duration
|
0 msec
Standard Deviation 13.61
|
-1.0 msec
Standard Deviation 9.34
|
|
Change From Baseline in Electrocardiogram Parameters
QT interval
|
2.4 msec
Standard Deviation 22.19
|
-3.2 msec
Standard Deviation 32.57
|
|
Change From Baseline in Electrocardiogram Parameters
QTcB interval
|
1.1 msec
Standard Deviation 56.32
|
10.1 msec
Standard Deviation 51.80
|
|
Change From Baseline in Electrocardiogram Parameters
QTcF interval
|
3.0 msec
Standard Deviation 55.83
|
6.9 msec
Standard Deviation 50.80
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)Population: Vital signs were assessed in the Safety Analysis Set in participants with available data.
Outcome measures
| Measure |
Nabiximols
n=62 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=61 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Change From Baseline in Electrocardiogram Pulse Rate
|
-6.6 beats/minute
Standard Deviation 8.76
|
-2.5 beats/minute
Standard Deviation 9.87
|
SECONDARY outcome
Timeframe: Baseline, Day 15, and Day 21Population: Suicidal ideation or behavior was assessed in the Safety Analysis Set.
The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.
Outcome measures
| Measure |
Nabiximols
n=66 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=65 Participants
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation, Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation, Active with any methods (not planned) without intent to act
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal behavior, Actual attempt (non-fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation, Active with any methods (not planned) without intent to act
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal behavior, Actual attempt (non-fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation, Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation, Active with any methods (not planned) without intent to act
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation, Active with some intent to act, without specific plan
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation, Active with specific plan and intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal behavior, Actual attempt (non-fatal)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation, Active with some intent to act, without specific plan
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation, Active with specific plan and intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Baseline, Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation, Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation, Active with some intent to act, without specific plan
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal ideation, Active with specific plan and intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Suicidal behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 15, Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
Day 21, Suicidal behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.Population: Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.
Plasma concentrations were assessed using blood samples collected at the timepoints specified.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 1, Predose
|
1.60 ng/mL
Standard Deviation 1.21
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 1, 0-2H postdose
|
0.78 ng/mL
Standard Deviation 0.77
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 1, 2-4H postdose
|
0.91 ng/mL
Standard Deviation 1.77
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 15, 0-2H postdose
|
1.13 ng/mL
Standard Deviation 1.20
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 15, 2-4H postdose
|
2.07 ng/mL
Standard Deviation 1.96
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 21, Predose
|
0.86 ng/mL
Standard Deviation 0.66
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 21, 0-2H postdose
|
1.50 ng/mL
Standard Deviation 1.77
|
—
|
|
Plasma Concentrations for Δ9-tetrahydrocannabinol (THC)
Day 21, 2-4H postdose
|
3.08 ng/mL
Standard Deviation 2.90
|
—
|
SECONDARY outcome
Timeframe: Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.Population: Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.
Plasma concentrations were assessed using blood samples collected at the timepoints specified.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 1, 2-4H postdose
|
0.79 ng/mL
Standard Deviation 1.00
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 15, 0-2H postdose
|
2.12 ng/mL
Standard Deviation 1.92
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 15, 2-4H postdose
|
2.91 ng/mL
Standard Deviation 2.23
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 21, Predose
|
1.77 ng/mL
Standard Deviation 1.42
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 21, 0-2H postdose
|
2.22 ng/mL
Standard Deviation 1.66
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 21, 2-4H postdose
|
3.75 ng/mL
Standard Deviation 3.10
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 1, Predose
|
19.54 ng/mL
Standard Deviation 32.94
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 1, 0-2H postdose
|
10.53 ng/mL
Standard Deviation 24.16
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 1, 2-4H postdose
|
6.49 ng/mL
Standard Deviation 9.91
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 21, Predose
|
77.59 ng/mL
Standard Deviation 74.28
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 21, 0-2H postdose
|
70.53 ng/mL
Standard Deviation 68.49
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 21, 2-4H postdose
|
76.31 ng/mL
Standard Deviation 59.57
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 1, Predose
|
1.31 ng/mL
Standard Deviation 1.87
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-OH-THC: Day 1, 0-2H postdose
|
1.17 ng/mL
Standard Deviation 1.52
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 15, 0-2H postdose
|
63.75 ng/mL
Standard Deviation 47.02
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) and 11-carboxy-Δ9-tetrahydrocannabinol (11-COOH-THC), for Δ9-tetrahydrocannabinol (THC)
11-COOH-THC: Day 15, 2-4H postdose
|
66.86 ng/mL
Standard Deviation 45.23
|
—
|
SECONDARY outcome
Timeframe: Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.Population: Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.
Plasma concentrations were assessed using blood samples collected at the timepoints specified.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 1, Predose
|
0.24 ng/mL
Standard Deviation 0.16
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 1, 0-2H postdose
|
0.46 ng/mL
Standard Deviation 0.55
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 1, 2-4H postdose
|
0.51 ng/mL
Standard Deviation 0.94
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 15, 0-2H postdose
|
1.11 ng/mL
Standard Deviation 0.84
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 15, 2-4H postdose
|
1.68 ng/mL
Standard Deviation 1.29
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 21, Predose
|
1.01 ng/mL
Standard Deviation 0.80
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 21, 0-2H postdose
|
1.40 ng/mL
Standard Deviation 1.28
|
—
|
|
Plasma Concentrations for Cannabidiol (CBD)
Day 21, 2-4H postdose
|
2.42 ng/mL
Standard Deviation 2.17
|
—
|
SECONDARY outcome
Timeframe: Period 1: Day 1: predose,0-2 and 2-4 hours (hr) postdose. Day 15: 0-2 and 2-4 hr postdose. Day 21: predose,0-1 and 2-3 hr postdose.Population: Plasma concentrations were assessed in the Pharmacokinetic Analysis Set in participants with available data.
Plasma concentrations were assessed using blood sample collected at the timepoints specified.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 1, Predose
|
0.18 ng/mL
Standard Deviation 0.07
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 1, 0-2H postdose
|
0.59 ng/mL
Standard Deviation 1.00
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 1, 2-4H postdose
|
0.27 ng/mL
Standard Deviation 0.24
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 15, 0-2H postdose
|
1.14 ng/mL
Standard Deviation 0.66
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 15, 2-4H postdose
|
1.33 ng/mL
Standard Deviation 0.76
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 21, Predose
|
1.15 ng/mL
Standard Deviation 0.80
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 21, 0-2H postdose
|
1.22 ng/mL
Standard Deviation 0.82
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-OH-CBD: Day 21, 2-4H postdose
|
1.59 ng/mL
Standard Deviation 0.98
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 1, 0-2H postdose
|
15.67 ng/mL
Standard Deviation 47.41
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 1, 2-4H postdose
|
4.49 ng/mL
Standard Deviation 3.50
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 15, 0-2H postdose
|
76.84 ng/mL
Standard Deviation 47.81
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 15, 2-4H postdose
|
79.78 ng/mL
Standard Deviation 46.27
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 21, Predose
|
88.95 ng/mL
Standard Deviation 69.64
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 21, 0-2H postdose
|
78.04 ng/mL
Standard Deviation 62.73
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 21, 2-4H postdose
|
88.32 ng/mL
Standard Deviation 62.52
|
—
|
|
Plasma Concentrations for Relevant Metabolites, 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD), for Cannabidiol (CBD)
7-COOH-CBD: Day 1, Predose
|
7.06 ng/mL
Standard Deviation 4.91
|
—
|
Adverse Events
Nabiximols
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nabiximols
n=66 participants at risk
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=65 participants at risk
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Nervous system disorders
Headache
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
0.00%
0/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
Other adverse events
| Measure |
Nabiximols
n=66 participants at risk
A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).
|
Placebo
n=65 participants at risk
A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
|
|---|---|---|
|
General disorders
Fatigue
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Nervous system disorders
Dizziness
|
15.2%
10/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
|
Nervous system disorders
Somnolence
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
1.5%
1/65 • Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place