A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. (NCT00711646) | Clinical Trial Compass
CompletedPhase 3
A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
United Kingdom189 participantsStarted 2002-06
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to give informed consent.
* Male or female, aged 18 years or above.
* Stable disease for at least three months prior to study entry, in the opinion of the investigator.
* Diagnosed with MS whose spasticity was not wholly relieved with the therapy at the time of study entry.
* Significant spasticity in at least two muscle groups defined as a score of two or more on the Ashworth Scale for each muscle group.
* Stable dose of current anti-spasticity medication for at least 30 days prior to study entry.
* Willing to maintain a stable dose of anti-spasticity medication and level of physiotherapy for the duration of the study.
* Clinically acceptable laboratory results at Visit 2.
* Willing, if female and of child bearing potential or male subjects with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
* No cannabinoid use (cannabis, Marinol® or Nabilone) for at least seven days before Visit 1 and were willing to abstain from any use of cannabis during the study.
* Able (in the investigators opinion) and willing to comply with all study requirements.
* Willing for the Home Office to be notified of his or her participation in the study (applicable to the UK centres only).
* Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* History of schizophrenia, other psychotic illness, sever…
What they're measuring
1
Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.