A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Takeda
Summary
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Description
The drug being tested in this trial is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1). This trial will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes. This trial was initiated in parallel with the parent phase 2 trials, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916), which included participants with NT1 and narcolepsy type 2 (NT2), respectively. This long-term extension (LTE) trial enrolled participants with both diagnoses from the tw…