Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
Key Inclusion Criteria:
• Subject has completed all scheduled visits in the treatment phase of their Core Study.
Key Exclusion Criteria:
- Subject is currently using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) other than the investigational medicinal product (IMP) and are 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.
- Subject has been part of a clinical trial involving an IMP 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).
- Subject has 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) OR 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results are available; subjects that entered the study and are later found not to meet this criterion should be withdrawn from the study.