A Study to Evaluate the Long-term Safety and Tolerability of TAK-861

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 165

Inclusion Criteria

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

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., Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage., Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure., 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; these participants may be included after approval by the sponsor or designee)., 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., 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., 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., Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS)., Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months., 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)., Participant has epilepsy or history of seizure., 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of TAK-861.;Secondary Objective: To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as assessed by the mean sleep latency from the Maintenance of Wakefulness Test (MWT)., To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score., To assess the effect of TAK-861 on cataplexy as assessed by the weekly cataplexy rate (WCR) (participants with narcolepsy type 1 [NT1] only).;Primary end point(s): Occurrence of at least 1 treatment-emergent adverse event (TEAE).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from baseline in the parent study in MWT mean sleep latency.;Secondary end point(s):Change from baseline in the parent study in ESS total score;Secondary end point(s):Change from baseline in the parent study in WCR using the patientreported Cataplexy Diary (participants with NT1 only)