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The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-05-03
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Eligible subjects entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction. Visits occurred at the end of treatment weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours.
GW-1000-02Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 166 | -1.22 | 1.76 |
| Placebo | 169 | -0.91 | 1.72 |
The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented.
Eligibility
primary outcomes
Time frame: 0-15 weeks
The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline.
secondary outcomes
Time frame: 0-15 weeks
The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented.
Time frame: Day 0 (Randomisation) and Day 99 (End of Treatment)
All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.
Time frame: 0-15 weeks
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time frame: 0-15 weeks
The number of subjects who experienced and adverse event during the course of the study is presented
Time frame: Day 0 (Randomisation) and Day 99 (End of Treatment)
Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.
Publications
No exact PMID-linked public article is currently readable locally.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 166 | 51 | - |
| Placebo | 169 | 42 | - |
All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 156 | -3.3 | 9.25 |
| Placebo | 160 | -2.8 | 7.81 |
The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 124 | -0.7 | 2.85 |
| Placebo | 139 | -0.6 | 2.37 |
The number of subjects who experienced and adverse event during the course of the study is presented
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | 156 | - |
| Placebo | 170 | 132 | - |
Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 115 | -2.1 | 17.37 |
| Placebo | 120 | 9.3 | 63.56 |
The carer of the subject gave their opinion of any noticeable change in the subject's overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of carers who reported an improvement at the end of treatment is presented.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | 72 | - |
| Placebo | 170 | 56 | - |
The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 162 | -0.1 | 10.26 |
| Placebo | 165 | 0.5 | 8.05 |
The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented.
Population: All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 166 | 21 | - |
| Placebo | 169 | 18 | - |
| Milestone | Sativex | Placebo |
|---|---|---|
| STARTED | 167 | 170 |
| COMPLETED | 150 | 155 |
| NOT COMPLETED | 17 | 15 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Irritability | General disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Asthenia | General disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Urinary Tract Infection | Infections and infestations | Sativex: 3 / 167 · Placebo: 2 / 170 |
| Orchitis | Infections and infestations | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Erysipelas | Infections and infestations | Sativex: 0 / 167 · Placebo: 2 / 170 |
| Sepsis | Infections and infestations | Sativex: 0 / 167 · Placebo: 2 / 170 |
| Burns third degree | Injury, poisoning and procedural complications | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Fall | Injury, poisoning and procedural complications | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Foot Fracture | Injury, poisoning and procedural complications | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Road Traffic Accident | Injury, poisoning and procedural complications | Sativex: 0 / 167 · Placebo: 1 / 170 |
| Dehydration | Metabolism and nutrition disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Tetany | Metabolism and nutrition disorders | Sativex: 0 / 167 · Placebo: 1 / 170 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Oesophageal Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Multiple Sclerosis Relapse | Nervous system disorders | Sativex: 2 / 167 · Placebo: 1 / 170 |
| Epilepsy | Nervous system disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Muscle Spasticity | Nervous system disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Somnolence | Nervous system disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Aggression | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Agitation | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Confusional State | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Depression | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Drug Dependence | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Insomnia | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Paranoia | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Suicidal Ideation | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Delusions | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Depression Worsened | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Urinary Retention | Renal and urinary disorders | Sativex: 1 / 167 · Placebo: 1 / 170 |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Peripheral Ischaemia | Vascular disorders | Sativex: 1 / 167 · Placebo: 0 / 170 |
| Phlebothrombosis | Vascular disorders | Sativex: 0 / 167 · Placebo: 1 / 170 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dizziness | Nervous system disorders | Sativex: 53 / 167 · Placebo: 17 / 170 |
| Somnolence | Nervous system disorders | Sativex: 24 / 167 · Placebo: 7 / 170 |
| Muscle Spasticity | Nervous system disorders | Sativex: 17 / 167 · Placebo: 13 / 170 |
| Headache | Nervous system disorders | Sativex: 15 / 167 · Placebo: 10 / 170 |
| Dysgeusia | Nervous system disorders | Sativex: 9 / 167 · Placebo: 0 / 170 |
| Disturbance in Attention | Nervous system disorders | Sativex: 7 / 167 · Placebo: 0 / 170 |
| Dysarthria | Nervous system disorders | Sativex: 7 / 167 · Placebo: 0 / 170 |
| Multiple Sclerosis Relapse | Nervous system disorders | Sativex: 5 / 167 · Placebo: 5 / 170 |
| Fatigue | General disorders | Sativex: 42 / 167 · Placebo: 32 / 170 |
| Asthenia | General disorders | Sativex: 26 / 167 · Placebo: 11 / 170 |
| Feeling Abnormal | General disorders | Sativex: 6 / 167 · Placebo: 1 / 170 |
| Malaise | General disorders | Sativex: 6 / 167 · Placebo: 1 / 170 |
| Nausea | Gastrointestinal disorders | Sativex: 53 / 167 · Placebo: 17 / 170 |
| Dry Mouth | Gastrointestinal disorders | Sativex: 24 / 167 · Placebo: 7 / 170 |
| Diarrhoea | Gastrointestinal disorders | Sativex: 15 / 167 · Placebo: 10 / 170 |
| Vomiting | Gastrointestinal disorders | Sativex: 9 / 167 · Placebo: 0 / 170 |
| Dyspepsia | Gastrointestinal disorders | Sativex: 7 / 167 · Placebo: 0 / 170 |
| Constipation | Gastrointestinal disorders | Sativex: 7 / 167 · Placebo: 0 / 170 |
| Insomnia | Psychiatric disorders | Sativex: 4 / 167 · Placebo: 5 / 170 |
| Anxiety | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 5 / 170 |
| Urinary Tract Infection Not Otherwise Specified | Infections and infestations | Sativex: 19 / 167 · Placebo: 21 / 170 |
| Vertigo | Ear and labyrinth disorders |
Time frame: Day 99 (end of treatment)
The carer of the subject gave their opinion of any noticeable change in the subject's overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of carers who reported an improvement at the end of treatment is presented.
Time frame: Day 0 (Randomisation) and Day 99 (End of Treatment)
The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.
Time frame: 0 - 15 weeks
The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented.
| Sativex: 19 / 167 · Placebo: 7 / 170 |
| Back Pain | Musculoskeletal and connective tissue disorders | Sativex: 7 / 167 · Placebo: 1 / 170 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Sativex: 7 / 167 · Placebo: 5 / 170 |