Trial Outcomes & Findings for Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis (NCT NCT04984278)

NCT ID: NCT04984278

Last Updated: 2024-12-11

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: TERMINATED
• Study phase: PHASE3
• Target enrollment: 56 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: 2024-12-11

Participant Flow

A total of 31 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at 7 clinic centers in Poland, Czech Republic, Spain, and United Kingdom.

After signing the ICF, participants with spasticity associated with MS participated in a Screening Period of up to 28 days; changes in the dosing regimen of the participants' current MS antispasticity medications, if any, were not made during this period.

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). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.	Placebo First, Then Nabiximols Participants who were randomized to receive matching placebo 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 GW-1000-02 (nabiximols) treatment for 21 days (starting at Day 31; Treatment Period 2). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.
Period 1 STARTED	16	15
Period 1 COMPLETED	15	14
Period 1 NOT COMPLETED	1	1
Period 2 STARTED	15	14
Period 2 COMPLETED	14	13
Period 2 NOT COMPLETED	1	1

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). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.	Placebo First, Then Nabiximols Participants who were randomized to receive matching placebo 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 GW-1000-02 (nabiximols) treatment for 21 days (starting at Day 31; Treatment Period 2). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.
Period 1 Withdrawal by Subject	1	0
Period 1 Other	0	1
Period 2 Adverse Event	1	0
Period 2 Other	0	1

Baseline Characteristics

Evaluation of 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=16 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). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.	Placebo First, Then Nabiximols n=15 Participants Participants who were randomized to receive matching placebo 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 GW-1000-02 (nabiximols) treatment for 21 days (starting at Day 31; Treatment Period 2). For each treatment period, participants titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment and then continue at the same dose level ±1 spray, divided into a morning dose and an evening dose for the remainder of the treatment period.	Total n=31 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	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	53.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	48.8 years STANDARD_DEVIATION 7.4 • n=7 Participants	51.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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

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=30 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=30 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)	-0.32 units on a scale Standard Error 0.072	-0.04 units on a scale Standard Error 0.075

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=30 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=30 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)	-0.34 units on a scale Standard Error 0.079	-0.09 units on a scale Standard Error 0.082

SECONDARY outcome

Timeframe: Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)

Population: TEAEs 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=30 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=30 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)	19 Participants	6 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=29 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=27 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	-2.5 mmHg Standard Deviation 11.27	-4.4 mmHg Standard Deviation 8.26
Change From Baseline in Blood Pressure Diastolic blood pressure	-1.9 mmHg Standard Deviation 7.74	-2.8 mmHg Standard Deviation 7.66

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=29 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=27 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	0.9 beats/minute Standard Deviation 8.97	-0.1 beats/minute Standard Deviation 9.13

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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=25 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 10^9 cells per liter Standard Deviation 1.68	-0.07 10^9 cells per liter Standard Deviation 1.94
Change From Baseline in Clinical Laboratory Test Values Neutrophils	0.071 10^9 cells per liter Standard Deviation 0.94	-0.399 10^9 cells per liter Standard Deviation 0.53
Change From Baseline in Clinical Laboratory Test Values Basophils	-0.01 10^9 cells per liter Standard Deviation 0.07	0 10^9 cells per liter Standard Deviation 0.07
Change From Baseline in Clinical Laboratory Test Values Eosinophils	0.04 10^9 cells per liter Standard Deviation 0.22	0.04 10^9 cells per liter Standard Deviation 0.19
Change From Baseline in Clinical Laboratory Test Values Lymphocytes	-0.041 10^9 cells per liter Standard Deviation 0.48	0.033 10^9 cells per liter Standard Deviation 0.48
Change From Baseline in Clinical Laboratory Test Values Monocytes	0.01 10^9 cells per liter Standard Deviation 0.22	0.03 10^9 cells per liter Standard Deviation 0.20
Change From Baseline in Clinical Laboratory Test Values Platelets	2.4 10^9 cells per liter Standard Deviation 23.20	4.6 10^9 cells per liter Standard Deviation 25.91

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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=27 Participants A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
Change From Baseline in Erythrocytes	-0.138 10^12 cells per liter Standard Deviation 0.20	-0.090 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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=25 Participants A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
Change From Baseline in Hemoglobin	-0.34 g/dL Standard Deviation 0.62	-0.21 g/dL Standard Deviation 0.53

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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=25 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	-0.012 ratio of packed cells to total volume Standard Deviation 0.0191	-0.009 ratio of packed cells to total volume Standard Deviation 0.0191

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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=25 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	-0.12 fL Standard Deviation 2.08	-0.38 fL Standard Deviation 1.89

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=27 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=25 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	0.1 pg Standard Deviation 0.64	0.1 pg Standard Deviation 0.57

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=29 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=27 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 QTcF interval	2.5 msec Standard Deviation 12.60	5.2 msec Standard Deviation 13.84
Change From Baseline in Electrocardiogram Parameters PR duration	-3.1 msec Standard Deviation 27.35	0.5 msec Standard Deviation 26.78
Change From Baseline in Electrocardiogram Parameters QRS duration	2.0 msec Standard Deviation 6.10	1.7 msec Standard Deviation 5.54
Change From Baseline in Electrocardiogram Parameters QT interval	5.4 msec Standard Deviation 15.35	4.0 msec Standard Deviation 17.79
Change From Baseline in Electrocardiogram Parameters QTcB interval	-0.8 msec Standard Deviation 16.04	4.9 msec Standard Deviation 15.20

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=29 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=27 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	-2.0 beats/minute Standard Deviation 9.42	-0.1 beats/minute Standard Deviation 7.78

SECONDARY outcome

Timeframe: Baseline, Day 15, and Day 21

Population: 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=30 Participants A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=30 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) 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) 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) Baseline, Suicidal ideation	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, 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 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	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, 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) 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	0 Participants	1 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 any methods (not planned) without intent to act	0 Participants	1 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	1 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	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, 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 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, 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 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	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 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	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
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

Adverse Events

Nabiximols

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nabiximols n=30 participants at risk A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).	Placebo n=30 participants at risk A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).
Ear and labyrinth disorders Vertigo	6.7% 2/30 • 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% 0/30 • 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.
General disorders Fatigue	13.3% 4/30 • 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% 0/30 • 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: ClinicalTrialDisclosure@JazzPharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place