A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Takeda
Summary
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
Description
The drug being tested in this study is called TAK-861. This study will look at how effective TAK-861 is for the treatment of narcolepsy type 1 and how well this effect is maintained over time. This study also evaluates how safe TAK-861 is and what adverse events may be associated with taking the drug and stopping the drug in participants with NT1. The study will enroll approximately 88 participants. All participants will take TAK-861 during the open-label (OL) treatment period. Participants who meet certain criteria at the end of the OL Treatment Period will be randomized to one of two treatm…
Eligibility
- Age range
- 16–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^2). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1. 3. The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\*06:02) or results from radioimmunoassay indicate the participant's CSF OX/hypocretin-1 concentration is ≤110 pg/mL (…
Interventions
- DrugTAK-861
TAK-861 tablets
- DrugPlacebo
TAK-861-matching placebo tablets
Locations (18)
- Takeda Site 1Redwood City, California
- Takeda Site 4Brandon, Florida
- Takeda Site 6Miami, Florida
- Takeda Site 7Southfield, Michigan
- Takeda Site 16Middletown, New Jersey
- Takeda Site 17Durham, North Carolina