Status:
COMPLETED
A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Spasticity
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
Detailed Description
This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sa...
Eligibility Criteria
Inclusion
- 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
- History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- Known history of alcohol or substance abuse.
- Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure.
- History of epilepsy.
- Female subject who was pregnant, lactating or planning pregnancy during the course of the study.
- Significant renal or hepatic impairment.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Subject who was terminally ill or was inappropriate for placebo medication.
- Any other significant disease or disorder which, in the opinion of the investigator, either put the subject at risk because of participation in the study, or influenced the result of the study, or the subject's ability to participate in the study.
- Regular levodopa (Sinemet®, Sinemet Plus®, Levodopa, L-dopa, Madopar®, Benserazide) therapy within seven days of study entry.
- Male subject receiving sildenafil (Viagra®) and unwilling to stop medication for the duration of the study.
- Subjects who were taking fentanyl (Durogesic®, Actiq®)
- Subjects who were taking antiarrhythmic medications.
- Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
- Known or suspected adverse reaction to cannabinoids.
- Planned travel outside the UK during the study (applicable to the UK centres only).
- Donation of blood during the study.
- Subjects who had participated in another research study in the 12 weeks prior to study entry.
- Subjects previously randomised into this study.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00711646
Start Date
June 1 2002
End Date
March 1 2004
Last Update
May 6 2023
Active Locations (1)
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1
Royal Berkshire Hospital
Reading, Oxfordshire, United Kingdom, RG1 5AN