Eli Lilly and Company (Lilly) has launched preventive treatment of migraine: outcomes for patients in real-world healthcare systems (TRIUMPH) clinical trial of its Emgality (galcanezumab-gnlm).

The TRIUMPH clinical trial is aimed at evaluating the real-world effectiveness of Emgality, compared to other preventive treatments for migraine, in people who intend to switch or start a new prescription treatment for migraine prevention.

Lilly Bio-Medicines neurology development vice president Gudarz Davar said: “The introduction of CGRP therapies, like Emgality, has provided physicians with valuable preventive treatment options for migraine. But historically and prior to this introduction, it’s been estimated that more than 40% of people who use migraine preventive treatments have a history of failure or switching.

“People with migraine deserve effective treatment options. The results from TRIUMPH will be enormously valuable to the migraine community in assessing the role of Emgality in long-term care and in comparison to other preventives.”

TRIUMPH clinical trial will enrol approximately 2,850 patients from the US, Europe and Asia

Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). It was approved by the FDA for the preventive treatment of migraine, in September 2018, and for the treatment of episodic cluster headache, in June 2019.

TRIUMPH clinical trial is expected to enrol approximately 2,850 patients from multiple sites across the US, Europe and Asia, to track the prescribing and preventive treatment choices for migraine treatment over a period of two years.

In addition, it will compare the switching patterns and discontinuation rates between Emgality, and other approved CGRP antibodies, including oral migraine preventive treatments and botulinum toxin A or B.

Lilly claimed that TRIUMPH clinical trial, along with OVERCOME trial, is a part its ongoing observational studies to expand the breadth and depth of its knowledge in the field of migraine.

Lilly Bio-Medicines senior vice president and president Patrik Jonsson said: “It’s important for us to examine the real-world impact of our therapies outside of a formal, clinical trial setting.

“By tracking physician and patient treatment decisions in the real-world, the results from TRIUMPH will contribute to a more comprehensive understanding of the real-world benefit of Emgality and its comparative effectiveness as a long-term treatment option.”

Recently, the company has started its LIBRETTO-431 clinical trial of LOXO-292 (selpercatinib), for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients.