A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia

Recruiting Phase 2 Phase 3 Interventional Study
Idiopathic Hypersomnia Narcolepsy Type 1 Narcolepsy Type 2
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 71
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Takeda · Industry
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About This Trial
Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions.…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: 1. Participant is willing and able to understand and fully comply with trial procedures and requirements. 2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial. 3. Participant has provided informe…
Contacts

Study Director

+1-877-825-3327

medinfoUS@takeda.com

CONTACT