Clinical Trials

The efficacy and safety of ST101 is currently being assessed in the SUMMIT and ASCEND Phase 3 trials. Satsuma believes that it is currently the only company seeking to establish the efficacy and safety of a DHE product by conducting a placebo-controlled Phase 3 efficacy trial.

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The Phase 3 SUMMIT trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of STS101 5.2 mg as an acute treatment for migraine that is being conducted in the United States. The SUMMIT study was designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. After establishing full eligibility, SUMMIT trial participants are randomized (1:1) to receive either: STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. 

The co-primary endpoints of the SUMMIT study are freedom from pain and freedom from most-bothersome-symptom (from among photophobia, phonophobia, or nausea) at two hours following administration of study medication. In addition, the SUMMIT trial design incorporates a variety of secondary endpoints and evaluations of qualitative performance parameters of STS101.

If you are a migraine suffer and would like information on participating in the SUMMIT study please click here.

More information can be found at clinicaltrials.gov


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The Phase 3 ASCEND trial is a multi-center, open-label, 12-month study to evaluate the safety and tolerability of STS101 5.2 mg as an acute treatment for migraine. Satsuma anticipates that data from the ASCEND trial, in conjunction with results from the ongoing STS101 SUMMIT Phase 3 pivotal trial, will support a New Drug Application filing for STS101. 

More information can be found at clinicaltrials.gov