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news.Trigemina (TI) has begun a Phase IIa clinical trial for its lead molecule in chronic daily headache (CDH) in collaboration with Egilius Spierings at MedVadis Research located outside of Boston. The study compares intranasal Oxytocin with placebo in patients suffering from at least 15 days of headache pain per month.
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The company plans to exploit a recently elucidated nasal-cerebral drug delivery route for targeting pain transmission and control pathways in cranial nerves and the CNS, enabling vast new possibilities for the treatment of acute and chronic pain.
In the Phase IIa proof-of-concept trial to evaluate the safety and efficacy of intranasal Oxytocin for CDH, 80 patients suffering from CDH is expected to be administered intranasal Oxytocin or placebo. Patients are monitored for reduction in pain and associated symptoms, as well as any adverse experiences. An interim analysis is planned at 40 patients.
Daniel Jacobs, CEO of Trigemina, said: “Based on preclinical data suggesting the plasticity of Oxytocin receptors in chronic pain states, and the ability to target those receptors with intranasal delivery, we believe that intranasal Oxytocin has the potential to significantly reduce pain in CDH patients and improve the lives of millions of people suffering from this debilitating condition.”