Phase I work
in volunteers has already commenced. These trials are being followed
rapidly by Phase II trials using the n
of 1 design. The first set of trials has already received Ethics
Committee approval. In n of 1 trials, each patient is the complete study
acting as his or her own control. This methodology has also been suggested
by the recent Institute
of Medicine Report as one which may prove to be a useful tool in the
investigation of the therapeutic benefits of cannabis-based medicine
extracts
Since each
patient is a study, this approach can be used to accommodate many patients
suffering from a variety of conditions who live in different geographical
areas. It is also a useful means by which we can try to bring patients
currently using herbal cannabis into the trials. We expect early trials to
encompass patients suffering from conditions including severe neuropathic
pain, neuroinvasive cancer,
trigeminal neuralgia, spinal
cord injury, pain and spasm of multiple
sclerosis and many others. The clinical programme will expand to
include group design Phase II studies.
Phase III
pivotal regulatory controlled trials will commence in 2000. During these
pivotal trials, n of 1 trials will continue to support evidence on other
conditions.
All patients
who wish to continue treatment with GW's medicines following conclusion of
the acute phase of their clinical trial will have the option to enter into
a long term safety study.
For
information about participation in clinical trials, click
here