Clinical Trials
Satsuma has completed three Phase 3 clinical trials, including the SUMMIT and ASCEND trials, designed to assess the safety and efficacy of STS101 in the acute treatment of migraine. Satsuma believes that the data from these Phase 3 Trials – in which a total of more than 1,500 subjects have treated more than 10,000 migraine attacks with STS101 – in combination with results from its Phase 1 comparative pharmacokinetic studies, will support a New Drug Application filing for STS101.
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.
More information can be found at clinicaltrials.gov
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.
More information can be found at clinicaltrials.gov