Prana presents new benchmark test to assess Huntington’s Disease patients in clinical trials
New testing method created by clinical investigators in Prana’s REACH2HD trial highlighted at the 17th Annual Congress of Parkinson’s Disease and Movement Disorders
Wednesday, 19 June, 2013: Melbourne-based Prana Biotechnology (ASX:PBT / NASDAQ:PRAN) has unveiled a world first, patient-reported outcomes study for Huntington’s Disease (HD) in a poster presentation at the 17th Annual Congress of Parkinson’s Disease and Movement Disorders being held in Sydney this week.
The Poster entitled: “The Huntington‘s Disease patient-reported outcome of problems: feasibility and applicability in clinical research (HD-PROP)” details a new benchmarking system to assess the problems experienced by people with HD. The HD-PROP test aims to overcome some of the challenges associated with assessing clinically relevant outcomes in HD where progressive motor, cognitive and psychiatric symptoms can interfere with comprehension of lengthy patient self-report questionnaires and communication of responses. The HD-PROP test may be a useful tool to evaluate Prana’s clinical trial results.
The HD-PROP test asks trial participants three questions in relation to their HD at the commencement of the trial. What problem is most bothersome? In what way is this problem bothersome? How severe is this problem?
The HD-PROP test was created by clinical investigators involved in Prana’s Phase 2 clinical trial of PBT2 known as the REACH2HD Study. This 109 patient trial is fully recruited and nearing completion.
Professor Ira Shoulson, one of four authors of the Poster and an internationally renowned clinical investigator, said: “This is the first time this type of patient response testing has been applied to HD, and we expect it will form an important part of future trials in HD."
“Patient-reported outcomes are an important area of focus for the US Food and Drug Administration (FDA) and along with clinical measures provide a more complete understanding of the relevance as well as safety and effectiveness of potential treatments.”
At the commencement of Prana’s Phase 2 trial, 97% of participants reported at least one bothersome problem, 87% reported at least two problems, and 67% reported at least three problems. Motor symptoms, cognitive symptoms, functional decline, and behavioral symptoms were the most commonly reported first, second and third problems.
Geoffrey Kempler, Chief Executive Officer of Prana Biotechnology added: “This new assessment gives us great insight into the issues and concerns of people with HD and has established an important benchmark that we can consider when assessing the final clinical results of our REACH2HD trial.”