Trial · NCT00681538
A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)
NCT00681538, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2011-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS). Trials, record NCT00681538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00681538
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)
- NCT number
- NCT00681538
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 572 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Spasticity, Multiple Sclerosis
- Interventions
- Sativex®, Placebo
- First posted
- 2008-05-21
- Last updated
- 2023-05-06
- Results first posted
- 2011-12-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | Subjects were asked "On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours" with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. They were asked to relate 'no spasticity' to the time prior to the onset of their spasticity. |
| Secondary | Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Baseline (Day 1) - End of treatment (last 7 days of Week 17) | A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders. |
| Secondary | Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | The subjects' baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B). |
| Secondary | Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked "On a scale of '0 to 10' please indicate how you your spasticity disrupted your sleep last night" with the anchors: 0 = 'did not disrupt sleep' and 10 = 'completely disrupted (unable to sleep at all)'. |
| Secondary | Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B). | Baseline (End of Week 4) - End of treatment (End of Week 17) | 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. |
| Secondary | Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs. | Baseline (End of Week 4) - End of treatment (End of Week 17) | Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition. |
| Secondary | Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B). | Baseline (End of Week 4) - End of treatment (End of Week 17) | 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. |
| Secondary | Subject Global Impressions of Change at End of Treatment (Phase B). | End of Treatment (WeeK 17) | |
| Secondary | Carer Global Impressions of Change at of Treatment (Phase B). | End of treatment (Week 17) | |
| Secondary | Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B). | End of treatment (week 17) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | Points on scale | MEAN | |
| SECONDARY | Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Baseline (Day 1) - End of treatment (last 7 days of Week 17) | participants | NUMBER | |
| SECONDARY | Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | Spasms per day | MEAN | |
| SECONDARY | Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B). | Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17) | Points on scale | MEAN | |
| SECONDARY | Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B). | Baseline (End of Week 4) - End of treatment (End of Week 17) | Score on scale | MEAN | |
| SECONDARY | Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs. | Baseline (End of Week 4) - End of treatment (End of Week 17) | For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo. | Score on scale | MEAN |
| SECONDARY | Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B). | Baseline (End of Week 4) - End of treatment (End of Week 17) | 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. | Seconds | MEAN |
| SECONDARY | Subject Global Impressions of Change at End of Treatment (Phase B). | End of Treatment (WeeK 17) | participants | NUMBER | |
| SECONDARY | Carer Global Impressions of Change at of Treatment (Phase B). | End of treatment (Week 17) | Sample sizes were reduced as not all subjects had a Carer to make this assessment. | participants | NUMBER |
| SECONDARY | Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B). | End of treatment (week 17) | Sample sizes were reduced as not all subjects had a Carer to make this assessment. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B). | Sativex (Phase B) | 3.68 | Standard Deviation 1.83 | Points on scale | |
| The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B). | Placebo (Phase B) | 4.56 | Standard Deviation 2.31 | Points on scale | |
| Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Sativex (Phase B) | 30% improvement in spasticity | 92 | participants | |
| Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Placebo (Phase B) | 30% improvement in spasticity | 60 | participants | |
| Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Sativex (Phase B) | 50% improvement in spasticity | 56 | participants | |
| Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline. | Placebo (Phase B) | 50% improvement in spasticity | 39 | participants | |
| Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B). | Sativex (Phase B) | 5.56 | Standard Deviation 10.33 | Spasms per day | |
| Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B). | Placebo (Phase B) | 7.70 | Standard Deviation 12.02 | Spasms per day | |
| Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B). | Sativex (Phase B) | 1.71 | Standard Deviation 1.65 | Points on scale | |
| Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B). | Placebo (Phase B) | 2.65 | Standard Deviation 2.45 | Points on scale |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A- 4 Weeks Single Blind | STARTED | Sativex (Phase B) | 572 | |
| Phase A- 4 Weeks Single Blind | STARTED | Placebo (Phase B) | 0 | |
| Phase A- 4 Weeks Single Blind | COMPLETED | Sativex (Phase B) | 538 | |
| Phase A- 4 Weeks Single Blind | COMPLETED | Placebo (Phase B) | 0 | |
| Phase A- 4 Weeks Single Blind | NOT COMPLETED | Sativex (Phase B) | 34 | |
| Phase A- 4 Weeks Single Blind | NOT COMPLETED | Placebo (Phase B) | 0 | |
| Phase B- Responders;12 Week Double-blind | STARTED | Sativex (Phase B) | 124 | |
| Phase B- Responders;12 Week Double-blind | STARTED | Placebo (Phase B) | 117 | |
| Phase B- Responders;12 Week Double-blind | COMPLETED | Sativex (Phase B) | 109 | |
| Phase B- Responders;12 Week Double-blind | COMPLETED | Placebo (Phase B) | 115 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Urinary tract infection | Infections and infestations | Sativex (Phase B) | 9 | 124 | |
| other | Urinary tract infection | Infections and infestations | Placebo (Phase B) | 12 | 117 | |
| other | Nasopharyngitis | Infections and infestations | Sativex (Phase B) | 4 | 124 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Phase B) | 3 | 117 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Sativex (Phase B) | 7 | 124 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Placebo (Phase B) | 8 | 117 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Sativex (Phase B) | 5 | 124 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo (Phase B) | 4 | 117 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Sativex (Phase B) | 0 | 124 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo (Phase B) | 5 | 117 |
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 (Phase B) | ||
| Total, all-cause mortality | Placebo (Phase B) | ||
| Total, other adverse events | Sativex (Phase B) | 66 | 124 |
| Total, other adverse events | Placebo (Phase B) | 40 | 117 |
| Total, serious adverse events | Sativex (Phase B) | 6 | 124 |
| Total, serious adverse events | Placebo (Phase B) | 1 | 117 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21362108 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sativex (Phase B) vs Placebo (Phase B): serious adverse events |
Source 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/NCT00681538
GET https://conductscience.org/api/trials/v1/NCT00681538/results?page=2