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Active, not recruiting Phase 3 Interventional

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

ClinicalTrials.gov ID: NCT07363720

Public ClinicalTrials.gov record NCT07363720. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 1:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07363720
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
98 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 28, 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026
Last update posted
Aug 31, 2026

2026

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
11
Facility City State ZIP Site status
Takeda Site 15 Redwood City California 94063
Takeda Site 19 Brandon Florida 33511
Takeda Site 22 Miami Florida 33155
Takeda Site 23 Southfield Michigan 48075
Takeda Site 20 Middletown New Jersey 07748
Takeda Site 24 Durham North Carolina 27710-4000
Takeda Site 25 Winston-Salem North Carolina 27103
Takeda Site 16 Cincinnati Ohio 45245
Takeda Site 18 Cleveland Ohio 44195
Takeda Site 17 Columbia South Carolina 29201
Takeda Site 21 Austin Texas 78731

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07363720, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07363720 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →