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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex | Active Comparator | Contains delta-9-tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each actuation delivers THC 2.7 mg and CBD 2.5 mg. Dose: 100 µL oromucosal spray to be administered up to a maximum of 12 sprays per day. There was an initial dose-titration period during which patients gradually increased their dose of study drug according to individual response and tolerability. |
|
| Placebo | Placebo Comparator | Oromucosal spray, containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Dose: 100 µL oromucosal spray to be administered up to a maximum of 12 sprays per day. There was an initial dose-titration period during which patients gradually increased their dose of study drug according to individual response and tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sativex | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Centre, Charles University | Prague | 128 08 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24151639 | Result | Abstracts of ECTRIMS (Congress of the European Committee for Treatment and Research in Multiple Sclerosis) 2013. October 2-5, 2013. Copenhagen, Denmark. Mult Scler. 2013 Oct;19(11 Suppl):8-597. No abstract available. | |
| 34532852 | Derived | Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sativex | Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0-48 weeks |
|
All adverse events occurring during the study (0-50 weeks) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment | The acute myocardial infarction resulted in the affected participant's death; this was not considered to be treatment-related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharma Ltd. | 0044 1223 266800 | rp@gwpharm.com |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
| Placebo | Drug | 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). |
|
|
| 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-48 weeks |
| 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. | 0-50 weeks |
| Lost to Follow-up |
|
| Withdrawal by Investigator |
|
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. |
| OG001 | 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. |
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Number | participants | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Number | participants | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Number | participants | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | visits | 0-48 weeks |
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Number | participants | 0-48 weeks |
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Mean | Standard Deviation | seconds | 0-48 weeks |
|
|
|
|
| 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. | All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis. | Posted | Number | participants | 0-50 weeks |
|
|
|
| 5 |
| 62 |
| 34 |
| 62 |
| EG001 | 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. | 0 | 59 | 19 | 59 |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Drug Withdrawal Syndrome | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Tetany | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oral Mucosal Erythema | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bacterial Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Face Injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Procedural Vomiting | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Vitamin D Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebellar Ataxia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cognitive Disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Multiple Sclerosis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscle Spasticity | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Trigeminal Neuralgia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anxiety Disorder Due To A General Medical Condition | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal Blistering | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lipoma Excision | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Application Site Discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
GW Pharma Ltd (GW) will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Minimally Better |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Minimally Better |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Minimally Better |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Active Suicidal Ideation Without Intent |
|
| Active Suicidal Ideation With Intent, No Plan |
|
| Active Suicidal Ideation With Intent and Plan |
|
The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal. |
| Wilcoxon (Mann-Whitney) |
| 0.088 |
| Hodges-Lehmann median difference |
| -1 |
| 2-Sided |
| 95 |
| -3 |
| 0 |
| Superiority or Other (legacy) |