Patients in New Migraine Study Use Electronic Diaries to Monitor Progress

Clinvest was approached by one of the largest pharmaceutical companies to “create and manage a [Mental Efficiency and Workload Test] for 500 subjects in a migraine trial occurring in 50 sites across the United States.” This will be the first time cognitive processing time will be tested in a major migraine study. To assist with the start of the study, Clinvest partnered with PHT Corporation, “the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 360 clinical trials worldwide.” Headache experts at Clinvest will use PHT’s LogPad System, “the industry’s leading electronic patient diary,” to decrease the burden study participants will face.

During the study, participants will use LogPad to record when they have a migraine, how long the migraine lasts, and its severity; keep track of their quality of sleep; and take electronic tests used to “measure their ability to perform simple calculations and react appropriately to stimuli.” The study will evaluate “the effect of barbiturates on pain, mental alertness, cognitive efficiency, and fine motor function for six months” with the results to be used as primary efficacy data.

The partnership between Clinvest and PHT has been positive so far. “We partnered with PHT to integrate our highly sensitive cognitive processing test system into the LogPad. The test results are seamlessly transferred into the PHT database and we can access it for the data analysis from almost anywhere. It’s perfect. We provide the objective assessment and PHT has surveys they include in the testing system. Because the LogPad automatically uploads the data to the database, the Clinvest analysis team can remotely review, download, analyze and report on the cognitive data in real time,” said Dennis L. Reeves, PhD, vice president at Clinvest.

“ePRO is more than digitized paper diaries,” said Phil Lee, PHT president and CEO. “Assessing a treatment’s ability to enhance or prohibit reduction of cognitive processing efficiency is a rapidly emerging center of study in the pharmaceutical industry… We are privileged to be working with Clinvest on this novel program and look forward to providing ePRO technology that helps clinical trial sponsors worldwide optimize data quality, program efficiency, and patient safety.”