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)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 70
Healthy Volunteers: f
View:
• The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m\^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.
• 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 (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
Locations
United States
California
Takeda Site 1
RECRUITING
Redwood City
Florida
Takeda Site 4
RECRUITING
Brandon
Takeda Site 6
RECRUITING
Miami
Michigan
Takeda Site 7
RECRUITING
Southfield
North Carolina
Takeda Site 17
RECRUITING
Durham
Takeda Site 18
RECRUITING
Winston-salem
New Jersey
Takeda Site 16
RECRUITING
Middletown
Ohio
Takeda Site 2
RECRUITING
Cincinnati
Takeda Site 15
RECRUITING
Cleveland
South Carolina
Takeda Site 3
RECRUITING
Columbia
Texas
Takeda Site 5
RECRUITING
Austin
Other Locations
France
Takeda Site 8
RECRUITING
Montpellier
Takeda Site 9
RECRUITING
Paris
Takeda Site 10
RECRUITING
Toulouse
Germany
Takeda Site 11
RECRUITING
Schwerin
Netherlands
Takeda Site 12
RECRUITING
Heemstede
Switzerland
Takeda Site 13
RECRUITING
Barmelweid
Takeda Site 14
RECRUITING
Bern
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2026-01-29
Estimated Completion Date:2026-10-02
Participants
Target number of participants:88
Treatments
Experimental: Double-blind RW Period: TAK-861
Participants on stable TAK 861 dose will receive the same dose of TAK-861 they were taking at the end of the OL treatment period, for up to 4 weeks in the double-blind RW period.