A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.
Condition: Spasticity; Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Intervention: Sativex®; Placebo
Intervention description: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours; containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spasticity; Multiple Sclerosis

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in
      subjects diagnosed with MS and spasticity.
    

Eligibility criteria:

        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, 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.