Biopharmaceutical company Trigemina has started patient enrolment in a Phase II trial of TI-001 (intranasal oxytocin) for the treatment of chronic migraines.
The Phase II trial, which is expected to enrol 96 chronic migraine patients at sites in Chile and additional sites in Argentina later in July, is designed as a placebo-controlled, double-blind, randomised withdrawal study.
Trigemina founder, chief scientist and Stanford University School of Medicine pain research director Dr David Yeomans said that around six million chronic migraine sufferers are present in the US alone.
"TI-001 has shown promising results in preclinical and preliminary clinical studies as being a safe and effective therapy for chronic migraine, an area where there is only one currently approved treatment," Yeomans said.
"This study is exciting to doctors and patients, not only because this could have a significant impact of the treatment of chronic migraine, but also because, unlike opioids, oxytocin is a safe and natural hormone with a remarkably benign side-effect profile."
The enrolment-enriched study’s primary clinical endpoint is to show the efficacy, tolerability and safety of TI-001 in chronic migraine patients.
The secondary objective is to identify the best Phase III dosage and discover interlukin-6 (IL-6) levels that serve as a potential biomarker for predicting efficacy.
TI-001 is likely to become the first non-invasive treatment for chronic migraine only after receiving approval from the US Food and Drug Administration.
Trigemina president and chief executive officer Charles Yeomans said; "Our goal is to address one of the most urgent global needs in drug development: an alternative to current opioid pain drugs and a safe and effective, and entirely new, migraine therapeutic."