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Case Study, Trigemina TI-001 for high frequency migraine
Trigemina’s TI-001 is a patented application of a formulation including oxytocin with a novel mode of action as a therapy for high frequency migraine. Open label data suggests that TI-001 holds the promise to be safe and effective in reducing moderate and severe headache day frequency among this population by more than 50%, with corresponding decreases in secondary migraine symptoms (nausea, vomiting etc.) and use of acute medications, a significant improvement compared to current drugs.
Following several single-dose trials in which TI-001 demonstrated promising analgesic effects, a Phase II trial was initiated in mid-2013 to seek analgesic effects and reduction in frequency of migraine headache days in a chronic and high frequency episodic migraine population.
The decision to use electronic patient reported outcomes (ePRO) data was an important part of Trigemina’s clinical strategy. Trigemina were concerned with data integrity and ePRO provided the necessary assurance that data was entered by the patient at the time the migraine episode occurred. In a multi-month trial such as Trigemina’s in which patients record their headaches round the clock, ePROs were considered a critical component of the study protocol.
There were a number of considerations for Trigemina when selecting the best approach to incorporate ePRO into the TI-001 study. Given the wide range of mobile devices available, the first was to select the most appropriate device for the planned study population. Since PROs had to be collected throughout the day, it was important to ensure that patients carried the device when they left their homes, so a smartphone was selected. Additionally using a smartphone to collect ePRO data allowed Trigemina to build SMS-based engagement into the ePRO design, which assists patients to remain engaged in the study until it is complete. The study required provisioning of smartphones to all patients to preserve psychometric validity and to provide a consistent user experience across the patient population for the collection of primary endpoint data. Exco InTouch provided the technology and services for the mobile ePRO implementation.
Impact of mobile ePRO on study progression
The selection of mobile ePRO had a positive impact on the conduct of the TI-001 study. Most notably through the immediate access to data it has provided for review and progression. For Trigemina this was not only important to monitor the progression of the study itself, the information they were able to glean from the ePRO data showed positive results to date and was a pivotal factor in securing further funding from investors. Additionally, the early results have enabled Trigemina to expand the study. The trial population has been increased almost threefold and sites in Australia and New Zealand have now been introduced to meet their desire to garner data from multiple ethnic populations.
Implementation of the ePRO solution within multi-country sites has also been a successful process. When it comes to the experience for sites, for Trigemina the key measure is the low level of technical support required from sites (and therefore patients). They have not received any concerns from sites regarding any aspect of implementation, including the complexity, size or weight of the provisioned devices that can be common with some ePRO solutions. During a recent visit to a site in New Zealand, which specializes in chronic conditions and manages a wide variety of ePRO solutions, Trigemina received feedback that they valued the small, simple phones provided because that’s what patients value. The sites were pleased that Trigemina and their vendor focused on simplicity and ease of use.
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