A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Overview

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). This study will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.

The study will enroll up to 160 patients from controlled studies conducted with TAK-861. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.

Participants with NT1 will receive the following dose from the parent study:

• TAK-861 Dose 1
• TAK-861 Dose 2
• TAK-861 Dose 3
• TAK-861 Dose 4 Participants with NT2 will receive either TAK-861 Dose 1 or TAK-861 Dose 2 from the parent study.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 108 weeks. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health), and will have a follow up assessment 4 weeks after last dose of study drug.

Eligibility

Inclusion criteria:

1. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria:

1. Participant has a moderate or severe ongoing treatment emergent adverse event (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
2. Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap.
3. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on any visit in the parent TAK-861 study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap.
4. Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap.
5. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
6. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
7. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).
8. Participant has epilepsy or history of seizure.
9. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
10. Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.
11. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
12. Participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell skin cancer.