Tonix Reports the First Patient Enrollment in the P-II Study (PREVENTION) of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs
Shots:
- The first patient has been enrolled in the P-II three-arm parallel study (PREVENTION) evaluating 2 different dosages of TNX-1900 (30 & 60 IU) vs PBO in a ratio (1:1:1) in 300 patients at ~25 sites across the US. The interim analysis results are expected in Q4’23
- The primary efficacy EPs is the mean change in no. of migraine headache days b/w 28-day run-in phase and the last 28-days of the treatment phase while the 2EPs incl. proportion of patients experienced a ≥50% reduction in no. of migraine headache days, mean change in no. of days using migraine abortive medications, and mean change in a migraine-specific QoL measure
- TNX-1900 is a drug-device combination product that uses an intranasal actuator device to deliver oxytocin to the nasal cavity
Ref: Tonix | Image: Tonix
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