According to AlzeCure Pharma, 7-8 percent of the US population is affected by peripheral neuropathy, increasing to 8 percent in older populations. With so many potential participants, reaching peripheral neuropathic pain sufferers in new ways to participate in drug trials could lead to tremendous improvements in many people’s lives.
LINK Medical is a full-service Nordic based contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe and beyond. The company, already Master Viedoc users and close collaborators with Viedoc, has strong Scandinavian roots and culture, providing high-quality service delivery based on respect, work integrity and a strong focus on solutions.
AlzeCure Pharma develops innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system. These include Alzheimer’s disease and pain – indications for which currently available treatment is extremely limited.
The Swedish pharmaceutical company approached LINK Medical to conduct a phase II, double-blind, placebo-controlled, randomized cross-over exploratory study with the non-opioid ACD440, a topical gel designed to relieve peripheral neuropathic pain.
Traditionally, pharmacological treatments have shown limited effectiveness in treating peripheral neuropathic pain. What’s more, only a third of patients with neuropathic pain receive drug treatment.
“Among them, only half experience pain reduction,” explains Adriana Miclescu, MD, PhD; Associate professor and senior consultant at Uppsala University Hospital’s Department of Medical Sciences, who helped conduct the study. “Most drugs used for neuropathic pain treatment are borrowed from other medical specialties like neurology and psychiatry.”
Due to the nature of peripheral neuropathic pain, as well as concerns related to the 2020-2022 global pandemic, sufferers were hesitant to take part in clinical trials. The team at LINK Medical turned to Viedoc for a solution.
“It was at the end of the pandemic, and we wanted to find ways that activities could be done remotely and digitally if needed – based on initial discussions and wishes from the clinic that were going to participate. Also we wanted to make participation in the trial easier and more efficient in general,” explains Hedda Magnusson, Director for Clinical Operations at Link Medical.
“I reached out to Henrik (Blombergsson, Co-Founder & COO at Viedoc) and to the Viedoc team to see what they could do. Specifically, the way we could find the patients and limit the need for them to come into the site physically in the beginning in connection with consent and screening, but also to enable FU visits to be performed remotely if preferred by the patients.”
A total of 145 patients registered for the trial, and, after the initial remote screening, 30 were disqualified for not meeting the criteria. The remaining patients underwent thorough review with over 23 individuals were ultimately screened for participation.
The trial spanned a timeline of 76 days from enrollment, beginning in August 2022 and concluding the following March. The process included a two-week enrollment period, followed by a one-week check-up, a two-week break, and subsequent visits during the following two weeks. It involved a placebo phase followed by an active substance phase.
Throughout the trial, the implementation of Viedoc's newly created remote capabilities, including video calls and telephone communication, played a vital role. An instructional video was created to provide participants with information about the study and its processes. Patients had the option to watch the video and access detailed patient information.
The flexibility of remote visits and the use of Viedoc's tools allowed for efficient engagement with patients, overcoming any challenges. Additionally, the team at LINK Medical remained adaptable, offering alternative solutions such as answering questions over the phone or providing support to older patients who faced difficulties with technology.
“I think this is a good thing to offer, because it gives people a personal touch and makes them feel like you're connected to it in a way,” adds Hedda. “This was the first time we pre-screened patients using Viedoc, and it was very helpful in getting the patients enrolled through the provided link.”
The results of the trial were promising. ACD440 demonstrated positive proof-of-mechanism results, showcasing its effectiveness in targeting the intended mechanism for chronic peripheral neuropathic pain. The drug exhibited a significant analgesic effect on pain induced by cold and heat, addressing a major issue faced by pain sufferers. Moreover, ACD440 was well tolerated as a topical gel, demonstrating its suitability for further clinical development as a local treatment.
“We need to consider the use of different tools for remote activities and digital activities for all studies moving forward, taking into account the patient group and what type of drug, where the sites are located,” says Hedda. “Having a platform like Viedoc, where you have all these tools to use, is really good.”
LINK Medical's successful utilization of Viedoc-powered remote screening exemplifies Viedoc’s commitment to innovative approaches in clinical research. By staying up to date with industry trends and implementing flexible solutions, Viedoc has once again showcased its ability to provide unique and tailored solutions to sponsors and CROs alike.
"Data capturing has been made easy because of viedoc, it is incredibly robust and easy to navigate"