Situation
Migraine is a common and debilitating neurological disease, affecting 39 million people in the United States alone. It has a considerable impact on patients’ lives, with 90% of people unable to work or function normally during an attack*. Current treatments, such as triptans, are not effective as headaches can reoccur within 24 hours after taking migraine medication — and also produce cardiovascular contraindications and warnings. High placebo response rates, averaging 29% in migraine studies, can mask the true therapeutic effect of a drug**.
In this phase III CNS migraine study, a biopharmaceutical company sought to evaluate the efficacy and safety of its drug for the acute treatment of migraines. The trial needed to demonstrate that the treatment was statistically differentiated from a placebo on two co-primary endpoints.
It was therefore vital for the sponsor to minimize the placebo response rate to ensure the trial results were as accurate as possible.
The eight month long trial took place in the US, involving 1,400 patients who suffered from acute migraines.
* https://migraineresearchfoundation.org/about-migraine/migraine-facts/
** https://link.springer.com/article/10.1007/s00228-005-0088-5
Solution
Clario’s eCOA Clinical Science team created a tailored online training program specific to the requirements of the sponsor’s migraine study. Patients were required to undertake the training, which was delivered via an interactive multimedia program with a comprehension quiz in both English and Spanish, and covered:
- Patients’ roles and responsibilities as study participants
- How to use the handheld devices to complete the electronic PatientReported Outcome Assessments (ePROs)
- What is meant by the placebo effect and how to answer questions about their symptoms accurately to minimize the placebo effect
Clario’s eCOA handheld solution was then used to deliver both the Migraine Quality of Life (MQOL) and the Profile of Moods (POMs) questionnaires as well as alarm reminders.
Impact
Clario’s patient training program cut the placebo response rate in half from that typically seen in migraine studies. This significant reduction delivered more accurate trial data and supported the successful outcome of the biopharma’s PIII trial.
“Ensuring the patient is informed and educated about the study and their vital role can increase ePRO data quality and reduce data variance. Providing purpose built participant training modules to better inform participants about the study and the ePRO assessments to be completed can lead to delivering higher-quality data in clinical trials, and can reduce placebo effect in certain indications” comments Bryan McDowell, Vice President, eCOA Science, Clario.
The trial also delivered high compliance rates. Investigative sites received email alerts when patients reported migraines, which allowed them to track when patients completed an assessment and follow-up when necessary.