Trial · NCT00391079
Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
NCT00391079, Phase 3, Completed, GW Pharmaceuticals Ltd; results first posted 2012-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS. Trials, record NCT00391079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00391079
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
- NCT number
- NCT00391079
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 339 participants, actual
- Lead sponsor
- GW Pharmaceuticals Ltd
- Conditions
- Multiple Sclerosis
- Interventions
- Sativex, Placebo
- First posted
- 2006-10-23
- Last updated
- 2013-06-24
- Results first posted
- 2012-07-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Pain Due to MS NRS Score | 14 weeks: Baseline - End of Treatment (last 7 days of treatment) | The pain NRS 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 the number that best describes your pain 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 pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline. |
| Primary | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline | 14 weeks: Baseline - end of treatment (last 7 days) | A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain 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 pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening. |
| Secondary | Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) | 14 weeks: Baseline - End of treatment (Week 14) | The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. |
| Secondary | Change From Baseline to End of Treatment in Break-through Analgesia Usage | 14 weeks: baseline - end of treatment (last 7 days) | Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment. |
| Secondary | Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form | 14 weeks: Baseline to end of treatment (last 7 days of treatment) | The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome. |
| Secondary | Change in Subject Global Impression of Change (SGIC) | Week 14 | A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to multiple sclerosis 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". At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported. |
| Secondary | Change in Sleep Disruption NRS | 14 weeks; Baseline to end of treatment (last 7 days) | The sleep disruption NRS 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Pain Due to MS NRS Score | 14 weeks: Baseline - End of Treatment (last 7 days of treatment) | Change in mean daily NRS score | units on a scale | MEAN |
| PRIMARY | Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline | 14 weeks: Baseline - end of treatment (last 7 days) | participants | NUMBER | |
| SECONDARY | Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) | 14 weeks: Baseline - End of treatment (Week 14) | Points on a scale | MEAN | |
| SECONDARY | Change From Baseline to End of Treatment in Break-through Analgesia Usage | 14 weeks: baseline - end of treatment (last 7 days) | tablets | MEAN | |
| SECONDARY | Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form | 14 weeks: Baseline to end of treatment (last 7 days of treatment) | All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form. | Points on a scale | MEAN |
| SECONDARY | Change in Subject Global Impression of Change (SGIC) | Week 14 | All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question. | percentage of subjects | NUMBER |
| SECONDARY | Change in Sleep Disruption NRS | 14 weeks; Baseline to end of treatment (last 7 days) | points on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Pain Due to MS NRS Score | Sativex | -2.02 | Standard Deviation 2.15 | units on a scale | |
| Change in Mean Pain Due to MS NRS Score | Placebo | -1.89 | Standard Deviation 2.33 | units on a scale | |
| Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline | Sativex | 84 | participants | ||
| Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline | Placebo | 77 | participants | ||
| Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) | Sativex | -14.24 | Standard Deviation 18.17 | Points on a scale | |
| Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) | Placebo | -11.44 | Standard Deviation 17.86 | Points on a scale | |
| Change From Baseline to End of Treatment in Break-through Analgesia Usage | Sativex | -1.16 | Standard Deviation 1.61 | tablets | |
| Change From Baseline to End of Treatment in Break-through Analgesia Usage | Placebo | -1.02 | Standard Deviation 2.07 | tablets | |
| Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form | Sativex | -1.5 | Standard Deviation 2.04 | Points on a scale | |
| Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form | Placebo | -1.4 | Standard Deviation 2.09 | Points on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sativex | 167 | |
| Overall Study | STARTED | Placebo | 172 | |
| Overall Study | COMPLETED | Sativex | 141 | |
| Overall Study | COMPLETED | Placebo | 156 | |
| Overall Study | NOT COMPLETED | Sativex | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Sativex | 15 | 167 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 6 | 172 | |
| other | Nausea | Gastrointestinal disorders | Sativex | 13 | 167 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 172 | |
| other | Dry mouth | Gastrointestinal disorders | Sativex | 12 | 167 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 10 | 172 | |
| other | Diarrhoea | Gastrointestinal disorders | Sativex | 7 | 167 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 172 | |
| other | Vomitting | Gastrointestinal disorders | Sativex | 5 | 167 | |
| other | Vomitting | Gastrointestinal disorders | Placebo | 5 | 172 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sativex | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sativex | 99 | 167 |
| Total, other adverse events | Placebo | 65 | 172 |
| Total, serious adverse events | Sativex | 3 | 167 |
| Total, serious adverse events | Placebo | 2 | 172 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23180178 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sativex vs Placebo: Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline | Trial comparisons |
| Sativex vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00391079
GET https://conductscience.org/api/trials/v1/NCT00391079/results?page=2