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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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…
Contacts