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…
Eligibility
- Age range
- 16–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1\. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment. Exclusion criteria: 1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial. 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS). 3. The participant has alanine aminotrans…
Interventions
- DrugTAK-861
TAK-861 tablets
Locations (52)
- Sleep Disorders Center of AlabamaBirmingham, Alabama
- Stanford Center for Sleep Sciences and MedicineRedwood City, California
- SDS Clinical Trials, Inc.Santa Ana, California
- Delta Waves LLC - Hunt - PPDSColorado Springs, Colorado
- Florida Pediatric Research InstituteOrlando, Florida
- Neurotrials ResearchAtlanta, Georgia