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Chordate Medical introduced its patented treatment method, Ozilia® Migraine, in 2021. It uses a CE-marked device that can replace existing medications with few to no side effects. Using neuromodulation, the Chordate solution retrains the autonomic reflex that leads to migraines, offering a non-pharmacological treatment approach.
To ensure both the safety and effectiveness of Ozilia® Migraine, Chordate established a clinical trial across 10 centers in England, Germany, and Italy, using Viedoc’s electronic patient-reported outcomes (ePRO) solution, Viedoc Me, to capture and manage patient data. The long study duration and international nature of the trial made patient recruitment and engagement challenging. By providing a simple, straightforward user experience, Viedoc Me supports more reliable results, giving Chordate’s study teams better data to analyze.
The treatment’s aim is to reduce the symptoms and frequency of migraine attacks without using medication. Some patients are hesitant to take migraine medication due to the side effects and ongoing cost, so Chordate’s CE-marked treatment provides a genuine alternative.
Chordate’s method of mechanical neurostimulation takes just 20 minutes in a clinical setting and has been shown to provide long-term migraine relief, with occasional follow-up treatments. A randomized, sham-controlled, double-blind study was needed to validate the initial findings, which were an outgrowth of using the same device on patients with chronic rhinitis. Ozilia® Migraine has been clinically proven effective for migraine treatment in peer-reviewed research published in the journal Neurology, highlighting its role as a safe, non-drug neuromodulation therapy.
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The study began in November 2023, but has faced the continuing challenge of recruiting sufficient numbers of participants in multiple countries. One major barrier to recruitment was, in fact, the introduction of new medications which have proven effective for some people, since patients would not need to enter a long-term trial to try and gain some relief from symptoms.
Another key issue of launching an international study relates to language barriers. Since patients would need to self-report their status every day, it was necessary to use tools that were multi-lingual and intuitive to use, to make it easier to recruit and retain sufficient numbers of participants.
Study results are crucial to validate the Chordate solution, as the value of a drug-free solution cannot be understated. While chronic migraines cannot be cured, the goal is to relieve the patient’s suffering. As Jan Hermansson, Clinical Scientific Officer at Chordate, put it, “If we could only eliminate even two days of migraines per month it would be considered a significant improvement for the patient.”
Chordate had prior experience with Viedoc’s eClinical suite to support earlier studies, making Viedoc Me the right choice for ePRO. Jan explained that they had used another system in the past, but it wasn’t popular with the patients, the doctors conducting the study, or Chordate’s own team. In contrast, Viedoc Me has proven to be flexible, user-friendly, and effective.
Compliance levels are high, he said, as patients are “very good about filling out the forms, because it is very easy and convenient.” He said that Viedoc Me’s “simple interface, automated reminders, and straightforward entry forms help ensure patients keep up with their daily inputs.” Additionally, he noted, Viedoc can support over 50 languages, which enables consistent studies in multiple countries.
From the study team’s perspective, Viedoc Me enables better data quality. Viedoc eliminates the need for clinics to manually enter data from paper diaries, which Jan jokingly described as "among the most miserable things you can engage in." This saves time and reduces the potential for errors. “Also, with Viedoc, the trial teams can easily browse data throughout the entire study period, and it’s easy to extract data for analysis,” he said, also noting that the platform is “stable, which is essential for reliability and smooth operation.”
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Jan noted that Viedoc’s in-house team worked with Chordate to build out the trial’s data management solution. He called the collaboration “fantastic” and added that the flexibility of the system and Viedoc’s responsiveness make it well suited to working across multiple countries with diverse patient groups.
He added that he had worked with Viedoc for many years, starting with a 2018 study, and while occasionally other data platforms had been chosen, he regularly returns to Viedoc because of how well-accepted it is by clinics, doctors, nurses, and study staff.
Jan cited Viedoc’s “simplicity and attractiveness” as key qualities, “because if clinics don't think it works or find it challenging to use, they won't prioritize finding patients for the study. The important thing is that it is attractive to users.”
Curious to learn more about how ePRO enhances patient engagement and trial efficiency? Dive into our breakdown of ePRO in clinical trials for practical insights.
It's a user friendly EDC with ease of implementing changes. The customer support is quick. I use it frequently for studies. There are multiple features compared to other EDC which provide ease of integration of all the expectation.
October 06, 2023
