Trial · NCT01606137

A Study of the Long-term Safety of Sativex Use

NCT01606137, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2012-08-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of the Long-term Safety of Sativex Use. Trials, record NCT01606137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01606137

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Trial

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

Title: A Study of the Long-term Safety of Sativex Use
NCT number: NCT01606137
Status: Completed
Phases: Phase 3
Enrollment: 507 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Multiple Sclerosis, Spasticity, Pain
Interventions: GW-1000-02
First posted: 2012-05-25
Last updated: 2023-05-06
Results first posted: 2012-08-23

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events as a Measure of Subject Safety.	Up to 1051 days	Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.
Secondary	Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.	0 - 52 weeks	Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Secondary	Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	0 - 52 weeks.	Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Secondary	Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.	0 - 52 weeks.	Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Secondary	Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	0 - 52 weeks.	Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
Secondary	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	Up to 1051 days	Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Secondary	Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	Up to 1051 days	Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Secondary	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	Up to 1051 days	Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
Secondary	Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	Up to 1051days	Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
Secondary	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.	Up to 1051	Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Adverse Events as a Measure of Subject Safety.	Up to 1051 days	All subjects who took part in the extension study were included in the analysis.	participants	NUMBER
SECONDARY	Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.	0 - 52 weeks	All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.	units on a scale	MEAN
SECONDARY	Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	0 - 52 weeks.	All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	units on a scale	MEAN
SECONDARY	Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.	0 - 52 weeks.	All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	units on a scale	MEAN
SECONDARY	Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	0 - 52 weeks.	All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	units on a scale	MEAN
SECONDARY	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	Up to 1051 days	All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	participants	NUMBER
SECONDARY	Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	Up to 1051 days	All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	participants	NUMBER
SECONDARY	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	Up to 1051 days	All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	participants	NUMBER
SECONDARY	Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	Up to 1051days	All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	participants	NUMBER
SECONDARY	Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.	Up to 1051	All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.	participants	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group17

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

Outcome	Group	Value	Spread	Units
Incidence of Adverse Events as a Measure of Subject Safety.	GW-1000-02	477		participants
Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.	GW-1000-02	-1.83	Standard Deviation 2.41	units on a scale
Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	GW-1000-02	-2.96	Standard Deviation 2.03	units on a scale
Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.	GW-1000-02	-3.11	Standard Deviation 1.90	units on a scale
Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.	GW-1000-02	-2.57	Standard Deviation 2.02	units on a scale
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	GW-1000-02	75		participants
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.	GW-1000-02	76		participants
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	GW-1000-02	112		participants
Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.	GW-1000-02	111		participants
Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.	GW-1000-02	193		participants

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	GW-1000-02	507
Overall Study	COMPLETED	GW-1000-02	245
Overall Study	NOT COMPLETED	GW-1000-02	262

Source ClinicalTrials.gov

Adverse events129

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	GW-1000-02	144	507
other	Headache Not Otherwise Specified (NOS)	Nervous system disorders	GW-1000-02	56	507
other	Somnolence	Nervous system disorders	GW-1000-02	43	507
other	Dysgeusia	Nervous system disorders	GW-1000-02	39	507
other	Multiple Sclerosis Aggravated	Nervous system disorders	GW-1000-02	39	507
other	Multiple Sclerosis Relapse	Nervous system disorders	GW-1000-02	30	507
other	Balance Impaired NOS	Nervous system disorders	GW-1000-02	27	507
other	Memory Impairment	Nervous system disorders	GW-1000-02	18	507
other	Disturbance in Attention	Nervous system disorders	GW-1000-02	17	507
other	Nausea	Gastrointestinal disorders	GW-1000-02	87	507

1 to 10 of 129Source ClinicalTrials.gov

See all 129 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GW-1000-02
Total, other adverse events	GW-1000-02	477	507
Total, serious adverse events	GW-1000-02	74	507

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22878432	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

GET https://conductscience.org/api/trials/v1/NCT01606137

GET https://conductscience.org/api/trials/v1/NCT01606137/events?page=2

API reference For AI assistants