A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 2

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of at least 1 treatment-emergent adverse event (TEAE).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change from baseline in the parent study in MWT mean sleep latency.<br /><br>- Change from baseline in the parent study in ESS total score.<br /><br>- Change from baseline in the parent study in<br /><br>- WCR using the patient-reported cataplexy diary (participants with NT1 only).</p><br>