A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis.

Jazz Pharmaceuticals1 site in 1 country337 target enrollmentMarch 2005

ConditionsMultiple Sclerosis

InterventionsSativex Placebo

DrugsSativex Placebo

Overview

Phase: Phase 3
Intervention: Sativex
Conditions: Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Enrollment: 337
Locations: 1
Primary Endpoint: Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis

Detailed Description

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Eligible subjects entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction. Visits occurred at the end of treatment weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

December 2005

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jazz Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to give informed consent.
•Aged 18 years or above.
•Ability (in the investigator's opinion) and willingness to comply with all study requirements.
•Diagnosed with any disease subtype of multiple sclerosis of duration greater than six months.
•Diagnosed with spasticity due to multiple sclerosis of at least three months duration and was not wholly relieved with their current therapy.
•Stable dose of anti-spasticity and non-pharmacological therapies for at least 30 days prior to the screening visit and willingness for these to be maintained for the duration of the study.
•Stable dose of disease modifying medications for at least six months duration prior to the screening visit and willingness to maintain this for the duration of the study.
•The last six daily diary spasticity numerical rating scale scores before randomisation had been completed and summed to at least
•Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.

Exclusion Criteria

•Concomitant disease or disorder that had symptoms of spasticity, or that may have influenced the subject's level of spasticity.
•Received a Botulinum Toxin injection within four months prior to the screening visit or unwillingness to stop receiving Botulinum Toxin injections for the relief of spasticity for the duration of the study.
•Had used cannabis within 30 days of study entry and unwillingness to abstain for the duration for the study.
•Had used cannabinoid based medications within 60 days of study entry and unwillingness to abstain for the duration for the study.
•History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
•Known or suspected history of alcohol or substance abuse.
•History of epilepsy or recurrent seizures.
•Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
•Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction.
•QT interval of \> 450 ms (males) or \> 470 ms (females) at Visit

Arms & Interventions

Sativex

Active treatment

Intervention: Sativex

Placebo

Control

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)

Time Frame: 0-15 weeks

The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline.

Secondary Outcomes

Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment(Day 0 (Randomisation) and Day 99 (End of Treatment))
Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment(Day 0 (Randomisation) and Day 99 (End of Treatment))
Incidence of Adverse Events as a Measure of Subject Safety(0-15 weeks)
Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline(0-15 weeks)
Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment(Day 0 (Randomisation) and Day 99 (End of Treatment))
Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)(0-15 weeks)
Carer Global Impression of Change at the End of Treatment(Day 99 (end of treatment))
Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline(0 - 15 weeks)