A Study of the Long-term Safety of Sativex Use

Inclusion Criteria

• •Willing and able to give informed consent.
• •Male or female aged 18 years or above.
• •Diagnosed with a condition categorised as one of the following: multiple sclerosis, spinal cord conditions, peripheral nerve injury or central nervous system damage associated with vascular, traumatic, infective, genetic or metabolic disease and whose symptom(s) were not wholly relieved by currently available therapy, prior to the previous study of GW-1000-02 or placebo.
• •Had participated in a GW clinical study using GW-1000-02 within the previous month.
• •Had shown tolerability to the study medication during the previous GW study.
• •Was expected, by the investigator, to gain clinical benefit from receiving long-term GW-1000-02.
• •Were 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.
• •Had not used cannabinoids (cannabis, Marinol or Nabilone) for at least seven days before Visit 1 (the exception being GW-1000-02 given as study medication) and were willing to abstain from any use of cannabis during the study.
• •Recent (within seven days) haematology and blood chemistry that was normal or considered clinically acceptable in view of the subjects underlying condition.
• •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.
• •Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.