Chelsea uses PHT's LogPad, SitePad Tablet for clinical study to treat Parkinson's patients with NOH

PHT Corporation announced that Chelsea Therapeutics is using PHT's LogPad® System and SitePad® Tablet for its ongoing clinical study in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension (NOH).

PHT is the global innovator in ePRO (electronic patient reported outcome) and PRO (patient reported outcome) solutions designed to maximize the collection of high quality data from patients for the improved health and safety of clinical trials participants. Chelsea Therapeutics is a biopharmaceutical company seeking approval for its lead therapeutic agent, Northera™ (droxidopa) for the treatment of symptomatic NOH.

After seeing preliminary data suggesting Northera treatment reduced the number of patient reported falls in a prior Phase III trial, Chelsea sought a reliable solution to accurately collect data on the frequency and circumstances of falls for its next Phase III trial. To meet this need, PHT developed a comprehensive daily Falls Diary specifically for this study using its LogPad® System, allowing Chelsea to evaluate Northera's potential to prevent falls associated with NOH in patients with Parkinson's disease.

The PHT LogPad® System is given to the study subjects for their daily Falls Diary. Chelsea is also using the PHT SitePad® Tablet at each investigation site for all questionnaires that are completed by either the physician or the patient.

Simon Pedder, Ph.D., President and CEO of Chelsea Therapeutics, explained, "The broad range of falls data collected using the LogPad® System during Part A of this study has provided compelling evidence that Northera treatment meaningfully reduces the number of falls experienced by patients with NOH associated with Parkinson's disease. Based on our confidence in this data, we are changing the primary endpoint of this trial to a reduction of falls and are confident that an eDiary is the best route to accurately capture this data in a uniform manner on a daily basis and support a future supplemental NDA filing to expand the label for Northera to include falls in Parkinson's patients that experience NOH."

The postural instability, dizziness and syncope that characterize symptomatic NOH increase the risk of falls in patients with Parkinson's disease. By treating NOH and reducing the frequency of falls, the new Chelsea drug could potentially make life much more enjoyable for patients with Parkinson's disease.

PHT President and CEO Phil Lee said, "We're delighted that an innovator like Chelsea Therapeutics is relying on PHT's ePRO Systems for this important study. Chelsea is a dynamic and burgeoning company with great talent and ideas. We look forward to a long and successful relationship between our two companies."

Source: PHT Corporation