Sativex (nabiximols)

P2, N=120, Recruiting, University of Birmingham | N=234 --> 120

P2, N=320, Recruiting, VA Office of Research and Development | Active, not recruiting --> Recruiting | N=21 --> 320

P3, N=139, Terminated, Jazz Pharmaceuticals | N=238 --> 139

Patients with recurrent MGMT promoter methylated GBM represent a relatively good prognosis sub-group of patients with GBM. However, their median survival remains poor and, therefore, more effective treatments are needed. The phase II design of this trial was chosen, rather than phase III, due to the lack of data currently available on cannabinoid efficacy in this setting. A randomised, double-blind, placebo-controlled trial will ensure an unbiased robust evaluation of the treatment and will allow potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development.

P2, N=44, Not yet recruiting, Michael, Levy M.D.,Ph.D.

P2, N=44, Not yet recruiting, Michael, Levy M.D.,Ph.D. | Phase classification: P2b --> P2

The protocol randomises on a 2:1 ratio between Nabiximols or matched placebo alongside standard dose temozolomide in patients at first recurrence of IDH wild-type GBM. ARISTOCRAT will provide robust clinical data on the role of cannabinoids in improving overall survival and the impact on QoL for patients with recurrent GBM.

There is moderate-certainty evidence that oromucosal nabiximols and THC are ineffective in relieving moderate-to-severe opioid-refractory cancer pain. There is low-certainty evidence that nabilone is ineffective in reducing pain associated with (radio-) chemotherapy in people with head and neck cancer and non-small cell lung cancer. There is low-certainty evidence that a single dose of synthetic THC analogues is not superior to a single low-dose morphine equivalent in reducing moderate-to-severe cancer pain. There is low-certainty evidence that CBD does not add value to specialist palliative care alone in the reduction of pain in people with advanced cancer.

P2, N=234, Recruiting, University of Birmingham | Not yet recruiting --> Recruiting

P2, N=234, Not yet recruiting, University of Birmingham