RecruitingNarcolepsy Type 1

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

Eligible age

16–70 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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.

Sponsor: Takeda

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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 aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (\>) 1.5 times the upper limit of normal (ULN).
✕ 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
✕ 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
✕ 6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
✕ 7. Participant has epilepsy or history of seizure.
✕ 8. 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.