Swing Therapeutics has partnered with virtual contract research organization Curavit Clinical Research to run a pivotal trial of its investigational digital therapeutic for fibromyalgia.
The 300-subject clinical trial, PROSPER-FM, began in February and is recruiting, or planning to recruit, participants at 18 sites across the US, according to its ClinicalTrials.gov listing. However, Swing sees benefits to combining the physical infrastructure with virtual enrollment and engagement capabilities.
“By using a mix of physical and virtual sites, we're hoping to reduce physical and geographic barriers to accessing the PROSPER-FM trial for participants. Our goal is to make it easier for people with chronic conditions like fibromyalgia to access digital therapies and making the trial available to participants remotely helps us to make that possible. Participants who live close to one of our qualified clinical sites may be asked to attend an initial study visit in person, but all other visits may be conducted over video or phone call,” said Mike Rosenbluth, CEO of Swing.
As a developer of digital therapeutics, in its case smartphone apps that support self-management skills, mindfulness activities, and more, Swing is potentially well positioned to realize the benefits of virtual clinical trials.
In decentralized clinical trials of traditional medicines, investigational products must be physically sent to participants, creating a range of logistical challenges. Providing therapy via a smartphone app eliminates the need for physical logistics and, in many cases, enables the capture of endpoints by the software. The question of how to perform the in-person assessments typically used to capture data is removed.
After determining that the hybrid model is a good fit for its clinical trial, Swing identified Curavit as the company equipped to help it deliver the study. Rosenbluth explained why Curavit, a company that claims it can improve patient enrollment by at least 10 times over a traditional trial, stood out as the best partner for the project.
“We chose Curavit because its virtual services model is aligned with our goal to improve access to digital therapeutics. Curavit will enable us to efficiently recruit participants that represent the entire patient population while also reducing barriers to access that make trial participation less burdensome for patients,” said Rosenbluth.
The partners are now working to enroll 300 subjects and randomize them to use either Swing’s digital acceptance and commitment therapy or its digital symptom tracker.
The primary endpoints of the clinical trial, which is scheduled to finish next year, are the revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and Patient Global Impression of Change (PGIC). FIQ-R assesses the health status of fibromyalgia patients by measuring factors such as physical functioning and depression, while PGIC evaluates all aspects of health to track changes in clinical status.