ANZCTR search results

Temporal lobe epilepsy is the most common form of focal epilepsy, and is commonly resistant to treatment with anti-seizure medications (ASMs). Successful epilepsy surgery is dependent on accurate delineation (and resection) of the epileptogenic zone (EZ). Astrocytes are a type of immune cell within the brain which are activated in response to acute injury or insult. Studies have demonstrated that activated astrocytes are present in surgically resected tissue of people with epilepsy, with other studies suggesting dysfunctional astrocytes contribute to seizure generation and propagation in drug resistant epilepsy. 18F-FDED, binds to the mono-amine oxidase B enzyme which is expressed on the surface of activated astrocytes, thus the present study will evaluate 18F-FDED PET as a technique for localising the EZ in patients with focal epilepsy.

This study in healthy volunteers aims to identify the range of safe single and multiple doses of AXN-027 Salt administered by mouth; to assess how the body handles AXN-027 Salt; how AXN-027 Salt contained in capsules compares to AXN-027 Salt contained in a tablet, what effect a high fat meal has on how the body handles AXN-027 absorption and to evaluate the safety of AXN-027 Salt compared to placebo. The results of this study will help identify appropriate doses of AXN-027 Salt to evaluate in future clinical trials.

This trial is a treatment specific appendix in a modular component of the Precision Therapies in Monogenic Epilepsies (PRIME) master protocol, for a series of N-of-1 studies of precision therapies in monogic epilepsies. It uses a within-participant, controlled, multi-crossover design to test the hypothesis that 4-AP, a potassium channel blocker, improves seizure control and/or ataxia associated with epilepsies due to gain-of-function (GoF) variants in the voltage-gated potassium channel genes KCNA1 (Kv1.1) and KCNA2 (Kv1.2).

All the patients with Rett Syndrome, previously on CBDV as part of the phase I trial, will be offered transition to Epidyolex, with monitoring for change in seizure frequency and severity, sleep behaviours and emergence of withdrawal symptoms. The study hypothesis is that patients with refractory epilepsy and Rett syndrome will respond to CBD (similar seizure frequency, seizure severity) when transitioned from CBDV.

OV329 [(S)-3-amino-4-(difluoromethylene) cyclopent-1-ene-1-carboxylic acid hydrochloride salt] is a gamma aminobutyric acid (GABA) aminotransferase (GABA-AT) inhibitor that is being developed as an antiseizure medication for rare seizure disorders in adults and pediatric patients. Part A will consist of up to 5 cohorts, comprising 8 participants each. Dosing will be initiated at 1 mg/day. Subsequent cohorts will be dosed as recommended by the Data Review Committee (DRC) based on the safety, tolerability and PK of OV329 from the previous cohort. Target engagement measured by MRS will also be considered in assessing the potential dose escalation as the dose will not be increased by more than 50% relative to the previous cohort if GABA levels are 2-fold increased. Part B will consist of 3 planned cohorts comprising 8 participants each with the first 2 cohorts and the third cohort will consist of 16 participants with 12 active and 4 placebo participants. Subsequent cohorts will be dosed as recommended by the DRC based on the safety, tolerability and PK of OV329 from the previous cohort (based on review of the Day 30 data, including ophthalmological assessments). Participants will be dosed for a total of 7 days.

Epilepsy is one of the most common, complex, and disabling neurological conditions worldwide. Mental health conditions are highly prevalent among people with epilepsy (PWE), with approximately 1 in 3 developing lifetime diagnoses of depression and anxiety disorders. However, there are significant barriers to accessing effective psychological treatment for PWE, including high costs, travel and mobility restrictions, cognitive difficulties (e.g. poor memory), and low involvement of mental health professionals in the routine care of PWE. As a digital mental health intervention, the Wellbeing Neuro Course offers an innovative solution to these barriers and aims to improve access to effective psychological care for adults with epilepsy within the Australian healthcare system. The Course uses the principles of cognitive behaviour therapy and compensatory cognitive rehabilitation to target several domains of mental health and cognitive function, and was designed specifically for people with neurological conditions. Digital mental health can be provided in both clinician-guided and unguided models, each with their own potential strengths and weaknesses. Guided models may be more expensive and complex given that trained clinicians must be recruited, yet previous research suggests they may be more efficacious than unguided models. In contrast, unguided models have more public health potential as they involve lower costs and are easier to implement into routine care settings, but may be less efficacious for those with complex presentations who would benefit from clinician support. The primary aim of this research project is to examine the comparative efficacy, cost-effectiveness, acceptability, safety, and long-term outcomes of the Wellbeing Neuro Couse when delivered under two different models of care (clinician-guided vs. unguided) for PWE experiencing emotional difficulties. The secondary aim of this research is to provide critical data of the characteristics of patient’s response to treatment to inform the wider dissemination of the program, including examination of the demographic and clinical predictors and moderators of treatment acceptability and efficacy. Consistent with previous trials, we hypothesise that: 1. Both the guided and unguided groups will result in substantial improvements in primary outcomes of depression and anxiety compared to the treatment-as-usual waitlist control (TAI-WLC) group. 2. There will be non-inferiority in clinical efficacy between the guided and unguided groups across the primary outcomes. 3. Both the unguided group and guided group will be cost-effective compared to TAU-WLC, but the unguided group will be more cost-effective relative to the guided group due to lower intervention costs.

Studies have shown that medicinal cannabis can reduce chronic pain, neuropathic pain, cancer pain, chemotherapy-induced nausea, spasticity in Multiple Sclerosis, and epileptic seizures in patients. However, the true gauge and extent of how medicinal cannabis affects patients in real-life conditions is not fully understood. To gain a better understanding of the real-life impact of medicinal cannabis, the QUEST study (ACTRN12621000063819) assessed the impact of medicinal cannabis on patients’ quality of life, symptoms, and function. This study, named the Global Quest Initiative, aims to expand on the work done by QUEST, with an additional focus on health economics. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been identified as eligible to receive medicinal cannabis, have not started any prescribed medicinal cannabis therapy in the previous 4 weeks, or have commenced medicinal cannabis no more than 2 days ago. Study details All participants will be asked to complete a number of questionnaires at the time of commencing medicinal cannabis, and every 1-2 months over a period of 1 year, to measure quality of life, health service use, prescribed medication use, anxiety and depression, fatigue, sleep, pain, work performance, and motor function, depending on the participant’s health indication. The questionnaires will take approximately 1 hour to complete, and will be accessed online via a link emailed to participants. Participants will not receive any treatments or have their treatment altered as part of this study. It is hoped that this study will show that medicinal cannabis improves quality of life, symptoms, and function in chronic pain sufferers and other patients, and is cost-effective for the treatment of these conditions.

This study will investigate a new drug, sodium selenate, for the treatment of drug-resistant temporal lobe epilepsy (TLE). Up to 124 patients with TLE will be recruited in to the study. Half of the patients will receive 26 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The primary outcome will be the a consumer co-designed DOOR-epilepsy rank, combining change in seizure frequency, adverse events, quality of life and ASM burden measures into a single outcome measure, compared between treatment and placebo groups over the whole 52 week period. Secondary outcomes include measures of seizures, epileptiform activity, cognitive and, neuropsychiatric outcome measures, quality of life, and medication burden at the end of 26 and 52 weeks (compared to baseline). Other measures will include safety and tolerability and exploratory biomarkers of treatment response.

Up to 30% of patients with epilepsy are resistant to current anti-seizure medications, i.e. drug-resistant epilepsy (DRE). Resective surgery of the epileptogenic regions is the most effective option to treat patients with DRE. Unfortunately, up to 60% of DRE patients are not suitable for resective surgery. Neuromodulation approaches are increasingly being utilized in patients with DRE. The current approved techniques use invasive neuromodulation, which require complex neurosurgery and could cause side effects, such as infection, bleeding, and non-target brain tissue damage. Focused ultrasound (FUS) is a novel, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy. NaviFUS System (a neuro-navigation guided focused ultrasound system) is one of the FUS technologies that uses low-intensity focused ultrasound (LIFU) phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures. The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity. Participants in this study will receive FUS treatment with the NaviFUS System, guided by the neuronavigation system. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi. Briefly, the study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.

To establish the (1) effectiveness, (2) cost-effectiveness and (3) acceptability of our machine learning (ML) model compared to usual care in selecting the first anti-seizure medication (ASM). Hypothesis: (1) seizure-free rate at 1 year of treatment with the first ASM will be higher in the machine learning group. (2) quality of life, depression and anxiety will improve more in the ML group, and ML model will be more cost-effective. (3) ML model will be acceptable to patients and clinicians. This is a multicentre randomised controlled trial (RCT) across all six states of Australia. Adults will be randomised 1:1 to ML Group (ASM recommended by the ML model) or the UC Group (ASM selected by the neurologist) and followed for 12 months. A sample size of 234 (including 10% dropout) participants will allow for measure of a minimum absolute difference of 20% in 1-year seizure-free rate on the first ASM between the study group (55% ML vs. 35% UC).