Trial Outcomes & Findings for Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis (NCT NCT04203498)
NCT ID: NCT04203498
Last Updated: 2024-05-08
Results Overview
The change in the average daily spasm count was assessed compared to the baseline period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
Nabiximols
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
Safety Analysis Set
|
67
|
70
|
|
Overall Study
COMPLETED
|
55
|
66
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
Nabiximols
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Overall Study
Decision by the investigator, GW, or authority
|
0
|
1
|
|
Overall Study
Withdrawal of patient consent
|
7
|
2
|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Drug not dispensed due to endpoint error
|
1
|
0
|
|
Overall Study
Did not receive IMP
|
2
|
0
|
Baseline Characteristics
Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Nabiximols
n=67 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
≥18 years to <45 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
≥45 years to <65 years
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Average daily spasm count was assessed in participants with available data in the Full Analysis Set defined as all patients from the Safety Analysis Set who signed the informed consent and are randomized by interactive response technology..
The change in the average daily spasm count was assessed compared to the baseline period.
Outcome measures
| Measure |
Nabiximols
n=67 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
Week 1 to 4
|
-2.23 daily spasm count
Standard Error 0.412
|
-1.62 daily spasm count
Standard Error 0.394
|
|
Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
Week 5 to 8
|
-3.42 daily spasm count
Standard Error 0.607
|
-2.62 daily spasm count
Standard Error 0.583
|
|
Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
Week 9 to 12
|
-3.84 daily spasm count
Standard Error 0.689
|
-3.11 daily spasm count
Standard Error 0.659
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Changes in Multiple Sclerosis Spasticity Scale were assessed in participants with available data in the Full Analysis Set defined as all patients from the Safety Analysis Set who signed the informed consent and are randomized by interactive response technology.
The MSSS-88 is a self-reported measure of the impact of spasticity (muscle stiffness and spasms) in MS. This 88-item scale captures the patient experience and impact of spasticity, including muscle stiffness, pain and discomfort, muscle spasms, effect on daily activities, ability to walk, body movement, patient feelings, and social functioning. Responses to individual questions can range from "1 - not at all bothered" to "4 - extremely bothered", ranging from 88 to 352 total score. Scores are summed and higher scores indicate poor clinical outcome. Least square means are being reported, with greater negative values indicating better outcome.
Outcome measures
| Measure |
Nabiximols
n=51 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=54 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score
Week 8
|
-21.64 unit on a scale
Standard Error 5.775
|
-26.11 unit on a scale
Standard Error 5.461
|
|
Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score
Week 12
|
-26.53 unit on a scale
Standard Error 5.807
|
-23.18 unit on a scale
Standard Error 5.426
|
SECONDARY outcome
Timeframe: From date of first dose of IMP up to 30 days after last dose, up to approximately 16 weeksPopulation: Treatment-emergent adverse events were assessed in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
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=67 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Number of Patients Reporting Any Treatment-emergent Adverse Events
|
47 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Clinical laboratory values were assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=62 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Clinical Laboratory Test Values
Basophils
|
-0.009 10^9 cells/liter
Standard Deviation 0.030
|
0.002 10^9 cells/liter
Standard Deviation 0.037
|
|
Change From Baseline in Clinical Laboratory Test Values
Eosinophils
|
-0.007 10^9 cells/liter
Standard Deviation 0.110
|
0.006 10^9 cells/liter
Standard Deviation 0.086
|
|
Change From Baseline in Clinical Laboratory Test Values
Leukocytes
|
0.146 10^9 cells/liter
Standard Deviation 1.095
|
0.139 10^9 cells/liter
Standard Deviation 1.881
|
|
Change From Baseline in Clinical Laboratory Test Values
Lymphocytes
|
-0.056 10^9 cells/liter
Standard Deviation 0.368
|
0.009 10^9 cells/liter
Standard Deviation 0.315
|
|
Change From Baseline in Clinical Laboratory Test Values
Monocytes
|
0 10^9 cells/liter
Standard Deviation 0.120
|
0.001 10^9 cells/liter
Standard Deviation 0.126
|
|
Change From Baseline in Clinical Laboratory Test Values
Neutrophils
|
0.217 10^9 cells/liter
Standard Deviation 1.004
|
0.083 10^9 cells/liter
Standard Deviation 1.788
|
|
Change From Baseline in Clinical Laboratory Test Values
Platelets
|
-0.085 10^9 cells/liter
Standard Deviation 42.392
|
5.290 10^9 cells/liter
Standard Deviation 49.972
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Erythrocytes were assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=62 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocytes
|
0.010 10^12 cells/liter
Standard Deviation 0.241
|
-0.007 10^12 cells/liter
Standard Deviation 0.251
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Hemoglobin was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=62 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin
|
-0.025 g/dL
Standard Deviation 0.735
|
-0.021 g/dL
Standard Deviation 0.726
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Hematocrit ratio was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
The hematocrit ratio measures the volume of red blood cells compared to the total blood volume.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=62 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Hematocrit Ratio
|
-0.002 ratio of packed cells to total volume
Standard Deviation 0.025
|
-0.002 ratio of packed cells to total volume
Standard Deviation 0.027
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Erythrocyte mean corpuscular hemoglobin was assessed patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=62 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
|
-0.156 pg
Standard Deviation 0.608
|
-0.005 pg
Standard Deviation 0.881
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Blood pressure was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Pressure
Systolic Blood Pressure
|
-1.6 mmHg
Standard Deviation 10.95
|
2.6 mmHg
Standard Deviation 11.31
|
|
Change From Baseline in Blood Pressure
Diastolic Blood Pressure
|
0.3 mmHg
Standard Deviation 8.20
|
2.7 mmHg
Standard Deviation 13.38
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Heart rate was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=60 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Heart Rate
|
2.5 beats/minute
Standard Deviation 7.70
|
0.4 beats/minute
Standard Deviation 10.14
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Electrocardiogram parameters were assessed in patients with available data in the Safety Analysis Set. defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Electrocardiogram Parameters
PR interval, aggregate
|
5.5 msec
Standard Deviation 20.51
|
1.3 msec
Standard Deviation 21.05
|
|
Change From Baseline in Electrocardiogram Parameters
QRS duration
|
1.9 msec
Standard Deviation 9.89
|
-6.5 msec
Standard Deviation 37.08
|
|
Change From Baseline in Electrocardiogram Parameters
QTcB interval
|
1.5 msec
Standard Deviation 29.58
|
-2.4 msec
Standard Deviation 33.29
|
|
Change From Baseline in Electrocardiogram Parameters
QTcF interval
|
2.9 msec
Standard Deviation 26.69
|
-3.2 msec
Standard Deviation 32.40
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Electrocardiogram heart rate was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=61 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Electrocardiogram Pulse Rate
|
-2.6 beats/min
Standard Deviation 10.21
|
0.5 beats/min
Standard Deviation 8.74
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Weight was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Weight
|
-0.338 kg
Standard Deviation 3.198
|
-0.394 kg
Standard Deviation 3.578
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Body mass index was assessed in patients with available data in the Safety Analysis Set defined as all participants who received at least 1 dose of study intervention in the study.
Outcome measures
| Measure |
Nabiximols
n=59 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=67 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Change in Body Mass Index
|
-0.086 kg/m^2
Standard Deviation 1.052
|
-0.159 kg/m^2
Standard Deviation 1.287
|
SECONDARY outcome
Timeframe: Screening up to Week 12Population: Suicidal ideation or behavior was assessed in the Safety Analysis Set. defined as all participants who received at least 1 dose of study intervention in the study
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=67 Participants
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 Participants
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Ideation, Non-specific active thoughts
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Ideation, Active any method no intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Ideation, Wish to be dead
|
1 Participants
|
1 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Ideation, Non-specific active thoughts
|
1 Participants
|
1 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Ideation, Active any method no intent
|
0 Participants
|
1 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Behavior, Actual attempt
|
0 Participants
|
1 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Suicidal ideation or behavior
|
1 Participants
|
1 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening: Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Ideation, Non-specific active thoughts
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Ideation, Active any method no intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Behavior, Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline: Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Ideation, Wish to be dead
|
1 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Ideation, Non-specific active thoughts
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Ideation, Active any method no intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Behavior, Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Suicidal ideation or behavior
|
1 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 2: Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Behavior, Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 4: Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Ideation, Non-specific active thoughts
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Ideation, Active any method no intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Ideation, Active intent to act, no plan
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Ideation, Active specific plan/intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Behavior, Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 8: Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Ideation, Wish to be dead
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Ideation, Non-specific active thoughts
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Ideation, Active any method no intent
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Behavior, Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Behavior, Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Behavior, Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Behavior, Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Behavior, Completed suicide
|
0 Participants
|
0 Participants
|
|
Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Week 12: Self-injurious behavior without suicidal intent
|
0 Participants
|
1 Participants
|
Adverse Events
Nabiximols
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nabiximols
n=67 participants at risk
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 participants at risk
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
3.0%
2/67 • Number of events 2 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
2.9%
2/70 • Number of events 2 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Infections and infestations
Cellulitis
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
0.00%
0/70 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/67 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
1.4%
1/70 • Number of events 1 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
1.4%
1/70 • Number of events 1 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/67 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
2.9%
2/70 • Number of events 2 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
Other adverse events
| Measure |
Nabiximols
n=67 participants at risk
Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
Placebo
n=70 participants at risk
Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
20.9%
14/67 • Number of events 15 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
7.1%
5/70 • Number of events 8 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
General disorders
Fatigue
|
11.9%
8/67 • Number of events 9 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
2.9%
2/70 • Number of events 3 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Nervous system disorders
Somnolence
|
10.4%
7/67 • Number of events 7 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
2.9%
2/70 • Number of events 2 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Ear and labyrinth disorders
Vertigo
|
9.0%
6/67 • Number of events 8 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
0.00%
0/70 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
General disorders
Asthenia
|
6.0%
4/67 • Number of events 4 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
2.9%
2/70 • Number of events 2 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Nervous system disorders
Taste disorder
|
6.0%
4/67 • Number of events 4 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
0.00%
0/70 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • Number of events 3 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
5.7%
4/70 • Number of events 5 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
|
Infections and infestations
Urinary tract infection
|
4.5%
3/67 • Number of events 3 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
5.7%
4/70 • Number of events 5 • Adverse event data were collected from baseline up to 14 days after the end of treatment visit, up to Day 99 (safety follow up visit).
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals Inc.
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place