Clinical Trials

Inclusion Criteria

• Has completed all scheduled visits in the treatment phase of their Core Study

Exclusion Criteria

• Is currently using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) other than the investigational medicinal product and is unwilling to abstain for the duration for the study
• Any history of suicidal behavior or any suicidal ideation of type four or five on the C-SSRS at visit 1
• Has been part of a clinical trial involving an investigational medicinal product during the inter-study period
• Female subject is of child bearing potential or male subject's partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom)
• Had significantly impaired hepatic function at the 'End of Treatment' visit of their Core Study or at visit 1 if re-assessed
  • Alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN
  • ALT or aspartate aminotransferase (AST) >3 x ULN and TBL >2 x ULN or international normalized ratio [INR] >1.5
  • This criterion can only be confirmed once the laboratory results are available
    • Subjects that enter the study and are later found not to meet this criteria should be withdrawn from the study