A Study of TAK-994 in Adults with Narcolepsy
Phase 2
- Conditions
- arcolepsy Type 1 (NT 1)
- Registration Number
- JPRN-jRCT2071210015
- Lead Sponsor
- onomura Hidenori
- Brief Summary
A safety signal for DILI emerged in the phase 2 studies of TAK-994; therefore, Takeda decided to suspend dosing immediately and prematurely discontinued the studies to allow for timely interpretation of the benefit-risk profile of TAK-994.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.
Exclusion Criteria
1. Participant has a clinically significant moderate or severe ongoing adverse event (AE) related to the study drug from the prior study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method