Multiple Sclerosis, Spasticity
Conditions
Keywords
Cognition, Mood
Brief summary
A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.
Detailed description
Eligible patients entered this 50 week multicenter, double-blind, randomised, placebo-controlled, parallel group study which evaluated the effect of Sativex on cognitive performance. At each scheduled clinic visit, patients were assessed for cognitive performance, mood, severity of spasticity, use of investigational medicinal products and number of visits to a healthcare professional. Primary efficacy comparisons were made between scores recorded during baseline and scores recorded at the end of treatment.
Interventions
DRUGSativex
Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
DRUGPlacebo
Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(ALL to be fulfilled): * Patient is willing and able to give informed consent for participation in the study. * Patient is aged 18 years or above. * Diagnosed with any disease sub-type of multiple sclerosis. * Diagnosed with symptomatic spasticity due to multiple sclerosis. * Patient has at least moderate spasticity in the opinion of the investigator. * Patient fulfils at least one of the two criteria below. Subject must be either: * Currently established on a regular dose of anti-spasticity therapy, or * Previously tried and failed anti-spasticity therapy. * Stable medication regimen for at least four weeks prior to study entry, for all medications which may have an effect on spasticity and/or cognition. * If the patient is taking disease modifying medication this must be at a stable dose for three months prior to the initial visit. * Willing and able to comply with all study requirements. * Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable. * Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
(if ANY apply): * Any history or immediate family of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. * Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures) that may influence the patient's level of cognition or mood. * Currently using or has used cannabis or cannabinoid-based medications within 30 days of study entry and unwilling to abstain for the duration of the study. * Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug. * Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products. * Female patients of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. * Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. * Patients who have received an investigational medicinal product within the 12 weeks prior to the initial visit. * Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study may influence the result of the study, or the patient's ability to participate in the study. * Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study. * Previously randomised to this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score. | 0-48 weeks | The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | 0-48 weeks | Patients were asked the following question, to be rated on a seven-point scale: Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below. The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'. The number of patients for each of the markers is presented at the final study visit. |
| Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | 0-48 weeks | Caregivers were asked the following question to be rated on a seven-point scale: How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit. |
| Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | 0-48 weeks | Physicians were asked the following question to be rated on a seven-point scale: How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit. |
| Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score. | 0-48 weeks | All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition. |
| Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score. | 0-48 weeks | The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition. |
| The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | 0-48 weeks | Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented. |
| Change From Baseline to End of Treatment in Timed 10-meter Walk Times. | 0-48 weeks | Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition. |
| Incidence of Adverse Events as a Measure of Patient Safety. | 0-50 weeks | The number of subjects who experienced an adverse event during the course of the study is presented. |
| Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional. | 0-48 weeks | At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sativex Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. | 62 |
| Placebo Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period. | 59 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Investigator | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Placebo | Sativex | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 61 Participants | 119 Participants |
| Age, Continuous | 48.21 years STANDARD_DEVIATION 10.381 | 48.95 years STANDARD_DEVIATION 8.954 | 48.59 years STANDARD_DEVIATION 9.642 |
| Region of Enrollment Czech Republic | 59 participants | 62 participants | 121 participants |
| Sex: Female, Male Female | 37 Participants | 39 Participants | 76 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 62 | 19 / 59 |
| serious Total, serious adverse events | 5 / 62 | 0 / 59 |
Outcome results
Primary
Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score. | 6.8 units on a scale | Standard Deviation 16.16 |
| Placebo | Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score. | 6.8 units on a scale | Standard Deviation 13.49 |
Comparison: The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).ANCOVA
Secondary
Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Caregivers were asked the following question to be rated on a seven-point scale: How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Better | 1 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Better | 12 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Worse | 0 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Better | 14 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | No Change | 11 participants |
| Sativex | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Worse | 3 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Worse | 3 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Better | 0 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Better | 6 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Better | 10 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | No Change | 18 participants |
| Placebo | Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Worse | 3 participants |
Comparison: Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.p-value: 0.014295% CI: [1.23, 6.31]Regression, Logistic
Secondary
Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.
All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score. | -10.6 units on a scale | Standard Deviation 11.26 |
| Placebo | Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score. | -7.7 units on a scale | Standard Deviation 10.7 |
Comparison: The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.p-value: 0.21295% CI: [-6.09, 1.37]ANCOVA
Secondary
Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.
At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional. | -0.6 visits | Standard Deviation 0.99 |
| Placebo | Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional. | -0.4 visits | Standard Deviation 1.3 |
Secondary
Change From Baseline to End of Treatment in Timed 10-meter Walk Times.
Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Change From Baseline to End of Treatment in Timed 10-meter Walk Times. | 6.2 seconds | Standard Deviation 55.34 |
| Placebo | Change From Baseline to End of Treatment in Timed 10-meter Walk Times. | 3.0 seconds | Standard Deviation 24.68 |
Comparison: The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.p-value: 0.55695% CI: [-11.51, 21.27]ANCOVA
Comparison: The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.p-value: 0.08895% CI: [-3, 0]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.
The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sativex | Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score. | -3.1 units on a scale | Standard Deviation 7.76 |
| Placebo | Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score. | -2.4 units on a scale | Standard Deviation 6.38 |
Comparison: The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.ANCOVA
Secondary
Incidence of Adverse Events as a Measure of Patient Safety.
The number of subjects who experienced an adverse event during the course of the study is presented.
Time frame: 0-50 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sativex | Incidence of Adverse Events as a Measure of Patient Safety. | 39 participants |
| Placebo | Incidence of Adverse Events as a Measure of Patient Safety. | 19 participants |
Secondary
Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Physicians were asked the following question to be rated on a seven-point scale: How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The number of patients for each of the markers is presented at the final study visit.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Better | 0 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Better | 26 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | No Change | 14 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Better | 15 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Worse | 3 participants |
| Sativex | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Worse | 0 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Better | 1 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Worse | 4 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Minimally Better | 15 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Better | 6 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Much Worse | 1 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | No Change | 29 participants |
| Placebo | Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
Comparison: Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.p-value: 0.001995% CI: [1.51, 6.21]Regression, Logistic
Secondary
Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Patients were asked the following question, to be rated on a seven-point scale: Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below. The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'. The number of patients for each of the markers is presented at the final study visit.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Much Better | 16 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | No Change | 13 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Minimally Worse | 1 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Minimally Better | 24 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Much Worse | 2 participants |
| Sativex | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Very Much Better | 2 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Much Worse | 1 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Very Much Better | 0 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Very Much Worse | 0 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Much Better | 6 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Minimally Better | 15 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | No Change | 27 participants |
| Placebo | Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment. | Minimally Worse | 7 participants |
Comparison: Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.p-value: 0.000195% CI: [1.96, 8.22]Regression, Logistic
Secondary
The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented.
Time frame: 0-48 weeks
Population: All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sativex | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Wish to be Dead | 0 participants |
| Sativex | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Non-specific Active Suicidal Thoughts | 0 participants |
| Sativex | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation Without Intent | 0 participants |
| Sativex | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation With Intent, No Plan | 0 participants |
| Sativex | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation With Intent and Plan | 0 participants |
| Placebo | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation With Intent, No Plan | 0 participants |
| Placebo | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation Without Intent | 1 participants |
| Placebo | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Wish to be Dead | 2 participants |
| Placebo | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Active Suicidal Ideation With Intent and Plan | 0 participants |
| Placebo | The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study. | Non-specific Active Suicidal Thoughts | 1 participants |