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

Recruiting Phase 2 Phase 3 Interventional Study
Narcolepsy Type 1
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
16 – 70
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

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.

Trial Locations
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Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the t…
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Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

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