NSW GOVERNMENT-SPONSORED CLINICAL
TRIAL FOR CANNABIS/CANNABIS PRODUCTS
IN PAEDIATRIC EPILEPSY
The NSW Government has committed to furthering research into the potential of
cannabis and cannabis-derived products for children with severe drug-resistant epilepsy
through the Sydney Children’s Hospital Network. The project should help establish NSW
as a leader in the field of cannabis-based research and improve the evidence base for
the use of these products.
EXPRESSIONS OF INTEREST
APPLICATIONS CLOSE 13 FEBRUARY 2015
NSW Cannabis Clinical Trials 2015
Introduction
The NSW Government has made a commitment to research that will enhance the evidence
base around the therapeutic use of cannabis and cannabis-derived products. The NSW
Therapeutic Cannabis/Cannabinoid Trial for Paediatric Epilepsy will be administered through
the Sydney Children’s Hospital Network (SCHN).
The SCHN is the home of the Paediatric Epilepsy Network NSW. This Network has
extensive experience in the conduct of clinical trials in the area of paediatric epilepsy.
The Network seeks academic and/or industry partners with experience in the area of drug
development and regulatory approval to support the clinical trials. Experience in cannabinoid
research, drug development and regulatory approval would be highly valued.
There will be a two stage process for all applications: a preliminary expression of interest
(EOI); followed by an invitation to respond a Request for Detailed Proposals to those
applicants who are selected by an independent panel.
1. Background
Worldwide, epilepsy is the most common, chronic, serious neurological disease. Drugresistant epilepsy is defined as failure of adequate trials of two tolerated, appropriately
chosen and used antiepileptic drugs. Epilepsy may also be improved by the adoption of a
special diet or, in some cases, surgical intervention. Around 33% of patients with epilepsy
remain resistant to treatment (i.e. they have seizures at least once every 12 months despite
adherence to their treatment regime). In children, around 3% of those with epilepsy have a
severe form of epilepsy that causes significant disruption to their lives, their intellectual
development and can cause a risk to life.
Increasing evidence points to a possible role for the endocannabinoid system in epilepsy.
Human and animal studies suggest epileptic activity is associated with changes in the levels
and distribution of receptors for cannabinoids in a particular part of the brain (the
hippocampus). Preclinical studies have suggested both a proconvulsant (causing seizures)
and anticonvulsant (reducing seizures) role for cannabinoids.
A recent Cochrane Review found that “there is a body of animal research that suggests that
it might be useful to evaluate the efficacy of cannabinoids for treatment of epilepsy in
humans. None of the existing clinical research is of sufficient quality or size to answer this
question. If the question were to be addressed, there would need to be a series of properly
designed, high quality and adequately powered trials.”
A number of children (and adults) have significant numbers of seizures each day. This
impacts not only on the child’s health and development, but has significant impact on those
who care for them.
The SCHN will conduct a trial as part of the series of properly designed high quality and
adequately powered trials to further the evidence in this area.
2. Criteria for the EOI

Applications are invited from individuals, institutions or industry that are currently able to
demonstrate experience in and an ability to provide appropriate support for the
establishment of and conduct of the clinical trial in close partnership with the SCHN.
Applications from NSW-based partners will be preferred, where other capacity is similar.
Expression of Interest
2
NSW Cannabis Clinical Trials 2015


Three areas of expertise have been identified and applicants can submit EOI’s for one or
more of these as below:
1. Clinical trial protocol development and management, clinical trial monitoring
and pharmacovigilance
2. Acquisition or development of a cannabis-derived product suitable for use in a
clinical trial for children with severe drug-resistant epilepsy
3. Regulatory expertise (particularly in import of banned substances and
Schedule 8 drugs) and bringing a novel drug to clinical trial
Experience in the field of cannabis-derived medicines management and research would
be an advantage for 2) and 3).
3. Application process
The application process will be held in two stages:
1. The submission of an EOI
2. Interview for clarification of project details may be requested.
The EOI and the CVs of relevant staff must be submitted to the SCHN prior to the deadline
of 5pm, 13 February 2015. Please see details below regarding the submission of
applications.
All submissions must use the application form provided in Appendix A below.
Late or incomplete application forms will not be considered.
Submission of applications
Applicants should submit one (1) electronic copy and six (6) hard copies of the EOI form and
associated documentation as listed within the EOI form. Applications should be single-sided
and A4 unbound. Electronic copies should be submitted as PDF format or .doc and be
named: [CHIEF INVESTIGATOR NAME]_Cannabis2015EOI_[DATE you emailed the
document]
SCHN requires all hard copies to be formally lodged. (i.e. in person, signed courier or
registered post)
Hard copies should be sent to:
by mail to:
OR
Jeff Wall
Associate Director Research
Sydney Children’s Hospitals Network
C/. The Children’s Hospital at Westmead
Locked Bag 4001
Westmead, NSW2145
in person or by courier to:
Jeff Wall
Associate Director Research
Sydney Children’s Hospitals Network
C/.The Children’s Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead, NSW, 2145
The electronic copy should be emailed to: Jeffrey.wall@health.nsw.gov.au
Enquiries may be directed to:
Jeff Wall
Associate Director of Research
Kids Research Institute
Tel. (02) 98451115 Email: Jeffrey.wall@health.nsw.gov.au
Both electronic and hard copy EOIs must be received by 5pm, 13 February 2015.
Expression of Interest
3
EXPRESSION OF INTEREST (EOI) FORM
NSW GOVERNMENT-SPONSORED CLINICAL TRIALS FOR CANNABIS/CANNABIS
PRODUCTS PAEDIATRIC EPILEPSY
DEADLINE 5PM, 13 FEBRUARY 2015
SECTION A – ADMINISTRATIVE SUMMARY
A.2
Organisation
Administering Institution Details
Institute Name
A.3
Organisation Contact
Select a Title: Choose a Title
Family Name:
Given Name:
Postal Address:
Telephone:
Mobile:
Email:
NSW Cannabis Clinical Trials 2015
SECTION B – EXPERIENCE
B.1
Summary
Summarise the application referring to significance of experience and areas of strength in
Clinical Trial protocol development and/or in manufacture/importing medicinal product for
NSW Health, website and media releases (maximum 2500 characters including spaces):
B.2
Short form proposal
1. Summarise the application referring to:



Clinical trial protocol development and management, clinical trial monitoring and
pharmacovigilance
Acquisition or development of a cannabis-derived product suitable for use in a clinical
trial for children with severe drug-resistant epilepsy
Regulatory expertise (particularly in import of banned substances and Schedule 8 drugs)
and bringing a novel drug to clinical trial
A separate short form can be used for each area of interest, if the researcher or group
wishes to be considered for more than one area.
Please include how the proposed partnership will meet the aims and use the guidelines
under each heading (maximum 500 words).
2. Organisational experience and team quality and capability
The expertise and experience of the individual/team/organisation relevant to the opportunity,
their successful delivery of the area of expertise being provided. An overview of previous
achievements of the organisation and team members should be provided. Include a biosketch for key staff.
Expression of Interest
5
NSW Cannabis Clinical Trials 2015
SECTION C – CANNABIS/CANNABIS PRODUCTS EXPERIENCE
C.1
Experience working with Cannabis/Cannabis products particularly Cannabinoids
(provide as much detail as possible). Relate to each area of interest, if possible:
Expression of Interest
6