ANZCTR search results

This study will investigate a new drug, sodium selenate, for the treatment of progressive supranuclear palsy (PSP). Up to 70 patients with PSP will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in volume of specific brain regions over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the change in mean diffusivity (a measure of neurodegeneration) on MRI, and the rate of disease progression observed in patients over the 52 weeks of treatment.

This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1 clinical study to evaluate the safety, tolerability, PK and PD of single oral ascending doses of iN1011 N17 in healthy subjects. This study will be conducted in approximately 80 healthy subjects in up to 10 sequential dose cohorts. Ten cohorts will consist of up to 8 subjects including 2 subjects receiving placebo and 6 subjects receiving iN1011 N17, after at least 10 hours of fasting. iN1011 N17 will be administered as a capsule or in a suspension formulation, with matching placebo.

AIR is an observational study that aims to determine if oxygen saturations (SpO2) of newborn infants 32 to 36 weeks gestation can reach recommended levels suggested by international expert guidelines. Currently, international guidelines recommend that respiratory support for newborn infants at or above 35 weeks gestation and those between 32-34 weeks gestation be initiated with air (21% oxygen) and 21-30% oxygen, respectively. For the first 10 minutes of life, guidelines also recommend that the amount of oxygen given to the infants should be adjusted to target SpO2 of healthy, full-term infants. This is part of multicentre study of hospitals in New South Wales Australia aiming to recruit 200 babies.

Propulsive metatarsalgia involves pain under the metatarsal heads during the “third rocker” phase of the gait cycle. Weil osteotomy is used to surgically treat metatarsalgia, by shortening the metatarsal via a distal oblique cut. Adjunct procedures are performed for lesser toe correction when required. While Weil osteotomies are commonly performed, complications include floating toe, joint stiffness and recurrence or transfer of metatarsalgia. “Wedge” osteotomy is a modification of Weil, involving a second incision to remove a slice of bone. The procedure purportedly reduces plantar translation of the metatarsal head, maintains metatarsophalangeal centre of rotation and improves intrinsic muscle function. However, in-vivo data for the clinical efficacy of this technique is limited. This study aims to investigate whether a wedge-cut Weil osteotomy compared to the traditional flat-cut technique is associated with increased pain relief and fewer complications up to 12 months postoperatively in patients presenting with propulsive metatarsalgia. Patients will be recruited into an existing patient registry (ACTRN12620000331932) and will be randomised into the flat-cut or wedge-cut (control) Weil osteotomy groups prior to surgery. They will subsequently undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators.

An therapeutic diet targeting naturally-occurring bioactive chemicals has been suggested to relieve gastrointestinal symptoms. A major focus of this diet is salicylates. This study aimed to address a potential role of dietary salicylates in causing symptoms in patients with irritable bowel syndrome (IBS). A pilot, double-blind, randomised, cross-over trial of two-week low-versus high-salicylate diets was undertaken. All food was provided containing minimal quantities of other potential food triggers. Gastrointestinal and extra-intestinal symptoms were measured daily using a 100-mm visual-analogue-scale. We hypothesised that a low salicylate diet would improve symptoms compared to the high salicylate diet in the 10 patients with IBS who conducted the study.

Since emerging in late 2019, the coronavirus disease 2019 (COVID-19) has rapidly spread across the world, including Australia. The World Health Organisation (WHO) declared COVID-19 a pandemic on 11 March 2020. The virus responsible for COVID-19, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a positive sense single-stranded RNA virus which predominantly causes respiratory tract infection, with a wide spectrum of disease severity from mild upper respiratory tract symptoms to respiratory failure. Health care workers (HCW), the elderly and immunocompromise have a higher risk of developing COVID-19. This clinical trial will establish whether a hyperimmune intravenous immunoglobulin (HIVIG) preparation concentrated with antibodies to SARS-CoV-2 is safe when administered to healthy adults. The trial will also assess whether the anti-SARS-CoV-2 antibodies in the immunoglobulin preparation are pharmacokinetically equivalent to naturally generated antibodies when infused in the trial subjects. This is an open label, active control Phase 1/2 study to assess the safety, tolerability and pharmacokinetic (PK) profile of hyperimmune IG (HIVIG) to SARS-CoV-2 compared with SARS-CoV-2 convalescent plasma (CP) following a single IV infusion of antibodies at a titre of = 1:160 in healthy adults aged 18 years and over. Fifteen participants will be allocated to each study arm, with matching of participants occurring based on sex and age (18-29, 30-49 and greater than or equal to 50 years). The first 3 participants from each arm will comprise a sentinel group, subject to 24hr confinement post infusion. Safety assessment of the sentinel group will occur prior to subsequent enrolment within the arm. All participants may have up to 13 scheduled clinic visits from Screening until Day 182 (end of study). Participants will be subject to safety blood sampling and for PK at Day 1, Day 2, Day 3. Day 7, Day 14, Day 28 and Day 42. This trial will address a gap in current knowledge by investigating a new agent manufactured by a novel Australian technology in the prevention of COVID-19. If successful, this approach can be rapidly scaled up for implementation into clinical practice and contribute to the sustainability of the Australian healthcare system during the current pandemic.

A novel prebiotic product, targeted for microbiome modulation in patients with low levels of fibre intake and those prone to constipation.

The study will provide a full cognitive assessment of patients with MCI to confirm their diagnosis and likely underlying cause. There are three specific aims of the project: 1. Establish a cohort of well-characterised patients with neurodegenerative diseases presenting as mild cognitive impairment (MCI). 2. Create a repository of blood, brain imaging (MRI & PET) and CSF data for biomarker studies. 3. Implement a clinical model to increase physician referrals to clinical trials, through access to advanced imaging, neurocognitive screening, and cognitive neurologist assessments for people residing in the South Eastern part of Melbourne and rural areas in Victoria. The study will allow us the opportunity to collect a large database of MCI patients to gain greater insights in to risks, diagnosis and prognosis of the disease. Simultaneously it will provide patients with a clearer understanding of their disease (through use of research only tools) and increase referrals in to clinical trials of potentially beneficial treatments for patients with MCI.

LEGO® therapy is a proven intervention that uses a child’s natural interest to motivate learning and to collaboratively build a LEGO® set with others through the social division of labour.. It has been found to be effective in increasing social skills and reducing maladaptive behaviours in younger children with autism spectrum disorder (ASD), however, there is limited information about the effectiveness of LEGO® therapy for children over the age of 13 years. LEGO® robotics therapy – which uses the principles of LEGO® therapy applied to LEGO® robotics – may be an age-appropriate intervention to reduce anxiety and increase social skills in adolescents with ASD. The primary aim of this Phase 1 clinical trial is to investigate whether LEGO® robotics therapy can reduce anxiety and increase social skills and school engagement in adolescents aged 13-16 years with ASD. The second aim is to measure the engagement, utility, and acceptance of LEGO® robotics with this cohort, while the third aim is to formally gather the views and perceptions of the intervention from all stakeholders (adolescents with ASD, parents, teachers, and LEGO® therapist/facilitators). The fourth and final aim is to develop a training manual for school staff and parents to support adolescents with ASD. The manual would support the reach, generalisation and longevity of the LEGO® robotics therapy program across educational, clinical, home and community settings. The findings of this study will inform the development of a larger randomised controlled trial.

This is a phase 1, single-center, randomized, open-label, 3-way crossover study to evaluate the pharmacokinetics of PBT434 after administration of a tablet formulation in the fed and fasted states and a powder in capsule formulation which has been utilized in previous Phase 1 investigations