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.
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