Status:
COMPLETED
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)
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Spasticity
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a...
Detailed Description
This 19 week, multicentre study was conducted in two phases. Phase A was a preliminary, single-blind four week treatment period to identify subjects with a capacity to respond to Sativex; eligible, co...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
- Diagnosed with any disease sub-type of MS of at least six months duration.
- Spasticity due to MS of at least three months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
- Subject fulfils at least one of the two criteria below. Subject must be either: Currently established on a regular dose of anti-spasticity therapy or Previously tried and failed, or could not tolerate suitable anti-spasticity therapy.
- Subject is currently receiving a stable regimen (for at least 30 days prior to study entry) of all medications that may have an effect on spasticity; and willing to maintain this for the duration of the study. If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
- Willing for his or her name to be notified to his or her primary care physician, and consultant and the responsible authorities for participation in this study, as applicable.
Exclusion
- Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity.
- Subject's medical history suggests that relapse/remission is likely to occur during the study (over the next 19 weeks) which, in the opinion of the investigator, is expected to influence the subject's spasticity.
- Currently receiving a prohibited medication and unwilling to stop for the stated period prior to the screening visit and for the duration of the study.
- Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity to cannabinoids.
- Significant cardiac, renal or hepatic disease.
- Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
- Female subject who is pregnant, lactating or planning pregnancy during the course of the study or for three months thereafter.
- Subjects who have received an IMP within the 12 weeks before Visit 1.
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
- Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study.
- Unwilling to abstain from donation of blood during the study.
- Travel outside the country of residence planned during the study.
- Subjects previously randomised into this study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT00681538
Start Date
January 1 2008
End Date
January 1 2009
Last Update
May 6 2023
Active Locations (1)
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1
Department of Neurology, Northampton General Hospital
Cliftonville, Northampton, United Kingdom, NN1 5BD