Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)

Summary

multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.

Timeline

Start

2021-11-23

Primary completion

2023-08-15

Completion

2023-08-31

Publications

• Randerath W, Grote L, Stenlof K, Fietze I, Chevts J, Buntinx E, Albares J, Kuhn K, Hansen C, Volp A, Hedner J; FLOW study investigators. Sultiame once per day in obstructive sleep apnoea (FLOW): a multicentre, randomised, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2025 Oct 25;406(10514):1983-1992. doi: 10.1016/S0140-6736(25)01196-1. Epub 2025 Oct 9.

Drugs

Indications