Phase II decentralized study evaluates transcutaneous auricular neurostimulation (tAN) for heavy menstrual bleeding, including participants with inherited bleeding disorders
NEW YORK–(BUSINESS WIRE)–#bleedingdisorders–For women and girls with bleeding disorders, heavy menstrual bleeding (HMB) is one of the most debilitating—and ignored—symptoms they endure. According to data from the National Bleeding Disorder’s (NBDF) Community Voices in Research registry, 46% of women with a bleeding disorder reported missing school or work due to it. Now, a Phase II decentralized clinical study is enrolling participants to test a drug-free alternative: transcutaneous auricular neurostimulation, a wearable technology that stimulates the nervous system through the ear to reduce heavy menstrual bleeding.
The LUNA Trial is being conducted by Spark Biomedical, a portfolio company of Pathway to Cures, NBDF’s venture philanthropy fund dedicated to accelerating new treatment options for the bleeding disorders community. The randomized, double-blind, sham-controlled Phase II study enrolling 80 participants in the United States, including adolescents ages 14–21 and adults ages 22–45 with a history of HMB with no known structural cause. The study will include women and girls diagnosed with von Willebrand disease. As a decentralized trial, participants can enroll from multiple locations, reducing common barriers to research participation.
“Heavy menstrual bleeding is one of the most common and challenging symptoms faced by women and girls with inherited bleeding disorders like von Willebrand disease, yet it is often under-recognized and left undertreated,” said Navid Khodaparast, PhD, Co-founder and Chief Scientific Officer of Spark Biomedical. “The LUNA Trial is designed to generate critical clinical evidence to support new, non-pharmaceutical approaches that could expand treatment options for these patients.”
The trial’s primary endpoint is the proportion of participants achieving a clinically meaningful reduction in menstrual blood loss compared to baseline. Secondary assessments include changes in menstrual cramp pain, overall symptom burden, and quality of life. Collaborating institutions include Oregon Health & Science University (OHSU), the University of Michigan, and Yale University. The LUNA trial is funded by Wellcome Leap through its The Missed Vital Sign program, which works to advance menstrual health as a critical and often overlooked indicator of mental health.
“For too long, heavy menstrual bleeding has been dismissed as something women and girls with bleeding disorders simply have to endure. The LUNA trial represents exactly the kind of innovative, patient-centered research Pathway to Cures was designed to advance, and we are proud to support Spark Biomedical in bringing this important work to the community that needs it the most,” said Teri Willey, Managing Director and Officer of Pathway to Cures.
Women and girls with a history of heavy menstrual bleeding who may be eligible are encouraged to learn more and consider enrolling. To view the full trial listing and eligibility criteria, visit the LUNA Trial: https://clinicaltrials.gov/study/NCT07326722?term=NA
About National Bleeding Disorders Foundation
The National Bleeding Disorders Foundation (NBDF) is dedicated to finding cures for inheritable blood and bleeding disorders and addressing and preventing these disorders’ complications through research, education, and advocacy, enabling people and families to thrive. Today, NBDF serves people across the United States with all bleeding disorders, including hemophilia, von Willebrand disease, rare factor deficiencies, and platelet disorders. The foundation also supports a network of 50 chapters across the country. To learn more, visit www.bleeding.org.
About Pathway to Cures
Pathway to Cures (P2C) is a venture philanthropy fund created to accelerate development of cures across all inheritable blood disorders. In collaboration with other organizations, P2C invests in innovative therapies and technologies, leveraging the deep resources and scientific community relationships of the National Bleeding Disorders Foundation. By reinvesting proceeds from investments back into the fund, P2C amplifies investment impact, supports promising companies, and builds a portfolio of investments that further NBDF’s mission. For more information, visit www.pathwaytocures.org.
About Spark Biomedical
Spark leverages neuroscience and engineering expertise to support healthcare providers and researchers with evidence-based tools designed for complex care situations where existing options may be limited. Spark has received funding from federal institutions such as the NIH and U.S. Department of Defense and partners with private and academic institutions. For more information, visit www.sparkbiomedical.com
Contacts
Jay Patel
Vice President of Communications
National Bleeding Disorders Foundation
646.530.2765
[email protected]
