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Recruiting Phase 2 Interventional

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

ClinicalTrials.gov ID: NCT06952699

Public ClinicalTrials.gov record NCT06952699. 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, 1:31 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 Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)

Brief summary

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

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Study identification

NCT ID
NCT06952699
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
88 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 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
May 5, 2025
Primary completion
Nov 29, 2026
Completion
Nov 29, 2026
Last update posted
Aug 19, 2026

2025 – 2026

United States locations

U.S. sites
31
U.S. states
15
U.S. cities
29
Facility City State ZIP Site status
Takeda Site 36 Auburn Alabama 36832 Recruiting
Takeda Site 39 Chandler Arizona 85224 Withdrawn
Takeda Site 40 Chula Vista California 91910 Recruiting
Takeda Site 14 Redwood City California 94063-3132 Recruiting
Takeda Site 10 Santa Ana California 92705-8519 Recruiting
Takeda Site 1 Colorado Springs Colorado 80918-3408 Recruiting
Takeda Site 48 Bradenton Florida 34209 Recruiting
Takeda Site 13 Brandon Florida 33511-5719 Recruiting
Takeda Site 46 Jacksonville Florida 32209 Recruiting
Takeda Site 44 Miami Florida 33155 Recruiting
Takeda Site 35 Miami Florida 33176 Recruiting
Takeda Site 3 Orlando Florida 32803-1468 Recruiting
Takeda Site 33 Orlando Florida 32807 Recruiting
Takeda Site 32 Atlanta Georgia 30328 Recruiting
Takeda Site 49 Bowie Maryland 20715 Recruiting
Takeda Site 50 Lansing Michigan 48911 Recruiting
Takeda Site 34 Lathrup Village Michigan 48076 Recruiting
Takeda Site 4 St Louis Missouri 63123-6968 Recruiting
Takeda Site 37 Middletown New Jersey 07748 Recruiting
Takeda Site 8 Denver North Carolina 28037 Recruiting
Takeda Site 6 Huntersville North Carolina 28078-5082 Recruiting
Takeda Site 41 Winston-Salem North Carolina 27103 Recruiting
Takeda Site 5 Cincinnati Ohio 45245-4500 Recruiting
Takeda Site 45 Cleveland Ohio 44106 Recruiting
Takeda Site 2 Columbia South Carolina 29201-2923 Recruiting
Takeda Site 38 Austin Texas 78731 Recruiting
Takeda Site 43 Dallas Texas 75235 Withdrawn
Takeda Site 42 El Paso Texas 79912 Recruiting
Takeda Site 47 Mansfield Texas 76063 Withdrawn
Takeda Site 7 San Antonio Texas 78229-4849 Recruiting
Takeda Site 11 Norfolk Virginia 23510-1021 Recruiting

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 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06952699, 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 19, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06952699 live on ClinicalTrials.gov.

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