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The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.
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
A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
GW-1000-02containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient
GW-4001-01Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline.
Population: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 0.57 | 1.06 |
| Placebo | 9 | -0.49 | 2.32 |
Eligibility
primary outcomes
Time frame: Day 0-35
The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline.
secondary outcomes
Time frame: Day 7 to 35
The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Time frame: Day 7 to time of last dose
Treatment failure was defined as follows: A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr: B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline.
Time frame: Day 0-35
The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.
Time frame: Day 0-35
The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain 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: Day 7 to 35
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your nerve pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of subjects wo reported an improvement is presented.
Publications
No exact PMID-linked public article is currently readable locally.
The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Population: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 2.56 | 5.57 |
| Placebo | 9 | -2.06 | 9.87 |
Treatment failure was defined as follows: A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr: B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline.
Population: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 5 | - |
| Placebo | 9 | 4 | - |
The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.
Population: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 3 | - |
| Placebo | 9 | 2 | - |
The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain 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: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 0.24 | 1.58 |
| Placebo | 9 | 0.12 | 0.97 |
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your nerve pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of subjects wo reported an improvement is presented.
Population: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 5 | - |
| Placebo | 9 | 4 | - |
The number of subjects who experienced an adverse event during the course of the study is presented.
Population: The safety analysis set comprised all subjects who received at least one dose of study medication.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 10 | 3 | - |
| Placebo | 9 | 2 | - |
| Milestone | Sativex | Placebo |
|---|---|---|
| STARTED | 10 | 9 |
| COMPLETED | 10 | 9 |
| NOT COMPLETED | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Headache | Nervous system disorders | Sativex: 2 / 10 · Placebo: 0 / 9 |
| Tremor | Nervous system disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Fatigue | General disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Insomnia | Psychiatric disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Onychomycosis | Infections and infestations | Sativex: 0 / 10 · Placebo: 1 / 9 |
| Back pain | Musculoskeletal and connective tissue disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Bone pain | Musculoskeletal and connective tissue disorders | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Weight decreased | Investigations | Sativex: 1 / 10 · Placebo: 0 / 9 |
| Stomach discomfort | Gastrointestinal disorders | Sativex: 0 / 10 · Placebo: 1 / 9 |
| Cataract | Eye disorders | Sativex: 0 / 10 · Placebo: 1 / 9 |
Time frame: Day 0 -35
The number of subjects who experienced an adverse event during the course of the study is presented.