About the Trial
The purpose of the Genetics of Pharmacoresistant Epilepsy (GenPhEp) Study is to improve our understanding of why a person may fail to become (and stay) seizure free with initial trials of antiseizure medications. The GenPhEp study aims to identify the genetic basis of why medications work for some people but not others, and why some medications cause side effects and others do not. To do this, researchers are seeking adults who have a diagnosis of epilepsy or recurrent seizures to participate in our study. We are looking for participants with any type of epilepsy, including from a brain tumour, injury, or whether the diagnosis is related to another condition, to help us find out how to predict the right (and wrong) medications for a person with epilepsy from the beginning.
The GenPhEp Study is a collaborative project conducted by researchers from QIMR Berghofer Medical Research Institute, a not-for-profit research institute located in Brisbane, the Queensland University of Technology, and the University of Melbourne. This research project has been approved by the Human Research Ethics Committee of the QIMR Berghofer Medical Research Institute (QIMRB-HREC).
Participation
Participating in this study can make important contributions to improving outcomes for individuals who experience epilepsy and their families.
The benefits of the research will include:
- Insight into epilepsy biology and anti-epileptic drug (AED) mechanisms of action;
- Development of patient profiles that predict the right (and wrong) AED to treat a person with epilepsy;
- Discovery of novel targets to develop new AEDs for those people whose seizures are not adequately controlled by current AEDs.
If you choose to participate, we will ask you to fill in an online survey about your experiences with epilepsy, including symptoms, seizures, medications, and emotional impacts. This is the core survey.
The survey also has additional modules that ask you about your experiences with other conditions that are known to impact individuals with epilepsy, like mood, sleep, memory, and headaches. These modules are optional.
We will also ask permission to access your Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) claims information through Services Australia. Providing MBS and PBS access is optional. You can still participate if you choose not to provide access.
We may also ask you to supply us with a sample of saliva, which we will use to extract DNA to look for genetic factors that influence epilepsy and anti-epileptic medication response.
How long does it take?
Participating in the study can require as little as 5 minutes of your time.
Depending on the number of questions you choose to answer, the core survey may take up to 15 minutes, while the additional optional modules might take up to an extra 15-20 minutes.
We may contact you after the core survey is completed to discuss if you would like to donate a saliva sample. If you agree to give a saliva sample, we will send you a sample collection kit through the post. Saliva samples can be collected in the privacy of your own home at a time that suits you. Providing a sample is easy and takes about 5-10 minutes. The saliva sample is sent back to us through the post using a pre-paid envelope.
- click the 'PARTICIPATE NOW’ button
- enter your contact details
- read the study information sheet
- consent to the study
- complete the online survey
- donate a saliva sample in a provided collection kit and return it to our laboratory in Brisbane using a pre-paid package.
Participate in the Trial
FAQ
Researchers are seeking adults who live in Australia who have a diagnosis of epilepsy, or recurrent seizures, to participate in our study. We are looking for participants with any type of Epilepsy, including from a brain tumour, injury, or whether the diagnosis is related to another condition have taken anti-epileptic medications.
Yes, we are interested in adults who have ever had a diagnosis of epilepsy, or recurrent seizures, in their lifetime.
Yes, if you have been diagnosed with Epilepsy and only had one seizure, you are eligible for the study.
Yes, we are interested in your experiences with seizures even if you have not received a diagnosis of epilepsy.
Yes, we would like to hear from people about their experiences when their medication is working as well as any times when their medication isn’t working, so we can look at the full picture.
Yes, even though this is a genetics study, you don’t need to have a family member with epilepsy or seizures to participate in this study.
To show our appreciation for the time and effort given by participants in the GenPhEp Study, each participant will receive an e-gift card to the value of $10 at the end of their participation in the study. There is no direct clinical benefit to participants. This is not a treatment-based study or clinical trial.
After completing the core survey, you may be asked to donate a saliva sample. Researchers will send a saliva collection kit together with a pre-paid return envelope to selected participants. We will extract DNA from the saliva to allow us to investigate genetic factors that influence anti-epileptic medications and their tolerability, and ultimately develop diagnostics that can tailor the best treatment for epilepsy patients.
Study participation is strictly confidential. All patient information provided will be maintained in accordance with the Commonwealth Privacy Act (1988) and National Health and Medical Research Council (NHMRC) Guidelines.
Your personal details, survey data and genetic information will all be stored in separate, firewalled password protected databases, and the only link between your personal details and your other data is your participant identification number. The databases and samples are stored separately – the data collection team can only access your personal and survey information, analysts can only access your survey information and genetic data, and laboratory staff can only access your biological sample and DNA. This separation protects the confidentiality of participants. When results are published, no individual results are included.
Participant DNA will be stored at QIMR Berghofer Medical Research Institute.
This research is not designed to provide any clinical results to participants. The study does not undertake individual analysis of each sample provided, but rather analyses all samples together. If you have a personal interest in obtaining a genetic test, we suggest you consider contacting a genetic testing entity that can provide such testing.
We want to provide as much feedback as possible to participants about the study.
In the consent form, we will ask you if you would like to receive study updates. If you agree, we will send updates via email during the study.
In this study, we are not conducting clinical genetic testing. We are also not providing participants any personal or family information from the research. Because of this, under the current Australian guidelines you do not need to disclose to Insurers that you participated in this study. For further information, refer to this summary article discussing insurance and genetic research, as well as Section 10.3 of the Financial Services Council policy on genetic testing and research (fsc.org.au).
Please wait half an hour after smoking, drinking, eating, chewing gum, or brushing your teeth before you provide your saliva sample.
If you are having trouble producing a sample, please visualise squeezing a half-lemon.
Please note that any volume is useful, even with bubbles.
If you are still unable to produce a sample, take a teaspoon of water, vigorously swish it around in your mouth and add that to the tube.
If you find the saliva collection kit is not suitable for you to use, please let us know as there are other sample collection options available that we can provide. Please call or email us using the contact details below if this is an issue.
Contact
You may find that the answers to your questions are listed in our Frequently Asked Questions Section.
If you require any further general queries about the GenPhEp Study, please see our contact details below:
E: epilepsy@qimrb.mailto:epilepsy@qimrb.edu.auedu.au
T: 1800 257 179
A: Locked Bag 2000
Royal Brisbane Hospital
Herston QLD 4029
Australia