Trial · NCT00711646

A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.

NCT00711646, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2012-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. Trials, record NCT00711646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00711646

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
NCT number: NCT00711646
Status: Completed
Phases: Phase 3
Enrollment: 189 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Spasticity, Multiple Sclerosis
Interventions: Sativex®, Placebo
First posted: 2008-07-09
Last updated: 2023-05-06
Results first posted: 2012-09-14

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.	0-52 days	The spasticity 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 the number that best describes your average spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline.
Secondary	Change From Baseline in Mean Ashworth Scale Score at the End of Treatment	Days 0 - 52	The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. 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 From Baseline in Mean Spasm Frequency Score at the End of Treatment	Days 0 - 52	Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.
Secondary	Change From Baseline in Mean Motricity Index Score for the Arms	Day 7 and 52	Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms 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	Patient's Global Impression of Change in Condition at the End of Treatment	Day 52	A 7-point Likert-type scale was used, with the question: 'Please assess the change in your condition 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 Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Secondary	Incidence of Adverse Events as a Measure of Subject Safety	Day 0-52	The number of subjects who reported an adverse event during the course of the study is presented.
Secondary	Change From Baseline in Mean Motricity Index Score for the Legs	Day 7 and Day 52	Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at 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	Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.	0-52 days	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mean Ashworth Scale Score at the End of Treatment	Days 0 - 52	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in Mean Spasm Frequency Score at the End of Treatment	Days 0 - 52		units on a scale	MEAN
SECONDARY	Change From Baseline in Mean Motricity Index Score for the Arms	Day 7 and 52	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	units on a scale	MEAN
SECONDARY	Patient's Global Impression of Change in Condition at the End of Treatment	Day 52	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	participants	NUMBER
SECONDARY	Incidence of Adverse Events as a Measure of Subject Safety	Day 0-52	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	participants	NUMBER
SECONDARY	Change From Baseline in Mean Motricity Index Score for the Legs	Day 7 and Day 52	All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.	Sativex		-1.18	Standard Deviation 1.83	units on a scale
Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.	Placebo		-0.63	Standard Deviation 1.62	units on a scale
Change From Baseline in Mean Ashworth Scale Score at the End of Treatment	Sativex		-0.64	Standard Deviation 0.56	units on a scale
Change From Baseline in Mean Ashworth Scale Score at the End of Treatment	Placebo		-0.53	Standard Deviation 0.58	units on a scale
Change From Baseline in Mean Spasm Frequency Score at the End of Treatment	Sativex		-0.37	Standard Deviation 0.77	units on a scale
Change From Baseline in Mean Spasm Frequency Score at the End of Treatment	Placebo		-0.26	Standard Deviation 0.74	units on a scale
Change From Baseline in Mean Motricity Index Score for the Arms	Sativex		3.64	Standard Deviation 14.82	units on a scale
Change From Baseline in Mean Motricity Index Score for the Arms	Placebo		3.07	Standard Deviation 10.08	units on a scale
Patient's Global Impression of Change in Condition at the End of Treatment	Sativex	Very Much Improved	2		participants
Patient's Global Impression of Change in Condition at the End of Treatment	Placebo	Very Much Improved	0		participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sativex	124
Overall Study	STARTED	Placebo	65
Overall Study	COMPLETED	Sativex	112
Overall Study	COMPLETED	Placebo	62
Overall Study	NOT COMPLETED	Sativex	12
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events58

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
other	Dizziness	Nervous system disorders	Sativex	40	124
other	Dizziness	Nervous system disorders	Placebo	7	65
other	Fatigue	General disorders	Sativex	13	124
other	Fatigue	General disorders	Placebo	4	65
other	Urinary Tract Infection NOS	Infections and infestations	Sativex	13	124
other	Urinary Tract Infection NOS	Infections and infestations	Placebo	6	65
other	Dry Mouth	Gastrointestinal disorders	Sativex	11	124
other	Dry Mouth	Gastrointestinal disorders	Placebo	4	65
other	Balance Impaired NOS	Nervous system disorders	Sativex	9	124
other	Balance Impaired NOS	Nervous system disorders	Placebo	1	65

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse 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	102	124
Total, other adverse events	Placebo	46	65
Total, serious adverse events	Sativex	4	124
Total, serious adverse events	Placebo	3	65

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17355549	RESULT	PubMed
25475413	DERIVED	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: Incidence of Adverse Events as a Measure of Subject Safety	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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