MedDataX Logo

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

NCT ID: NCT06952699

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2026-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

NCT06812078

Idiopathic Hypersomnia
RECRUITING PHASE2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy

NCT03748979

Healthy Participants Narcolepsy
COMPLETED PHASE1

A Study of Different Forms of TAK-994 in Healthy Adults

NCT04745767

Healthy Participants
COMPLETED PHASE1

Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy

NCT03332784

Healthy Participants and Patients With Narcolepsy
COMPLETED PHASE1

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783

Narcolepsy Type 2
ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Narcolepsy Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAK-360

Participants will receive TAK-360 tablets, orally, for 4 weeks.

Group Type EXPERIMENTAL

TAK-360

Intervention Type DRUG

TAK-360 tablet.

Placebo

Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

TAK-360 matching placebo tablet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAK-360

TAK-360 tablet.

Intervention Type DRUG

Placebo

TAK-360 matching placebo tablet.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of NT2.

Exclusion Criteria

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Takeda Site 14

Redwood City, California, United States

Site Status RECRUITING

Takeda Site 10

Santa Ana, California, United States

Site Status RECRUITING

Takeda Site 1

Colorado Springs, Colorado, United States

Site Status RECRUITING

Takeda Site 13

Brandon, Florida, United States

Site Status RECRUITING

Takeda Site 3

Orlando, Florida, United States

Site Status RECRUITING

Takeda Site 4

St Louis, Missouri, United States

Site Status RECRUITING

Takeda Site 8

Denver, North Carolina, United States

Site Status RECRUITING

Takeda Site 6

Huntersville, North Carolina, United States

Site Status RECRUITING

Takeda Site 5

Cincinnati, Ohio, United States

Site Status RECRUITING

Takeda Site 2

Columbia, South Carolina, United States

Site Status RECRUITING

Takeda Site 7

San Antonio, Texas, United States

Site Status RECRUITING

Takeda Site 11

Norfolk, Virginia, United States

Site Status RECRUITING

Takeda Site 28

Beijing, Beijing Municipality, China

Site Status RECRUITING

Takeda Site 29

Guangzhou, Guangzhou, China

Site Status RECRUITING

Takeda Site 27

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Takeda Site 17

Montpellier, Hérault, France

Site Status WITHDRAWN

Takeda Site 15

Paris, , France

Site Status RECRUITING

Takeda Site 22

Rome, Lazio, Italy

Site Status RECRUITING

Takeda Site 31

Verona, Veneto, Italy

Site Status RECRUITING

Takeda Site 23

Bologna, , Italy

Site Status RECRUITING

Takeda Site 24

Kohoku-ku, Yokohama-Shi, Kanagawa, Japan

Site Status RECRUITING

Takeda Site 9

Kumamoto, Kumamoto, Japan

Site Status RECRUITING

Takeda Site 30

Urasoe-Shi, Okinawa, Japan

Site Status RECRUITING

Takeda Site 20

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Takeda Site 26

Sumida-Ku, Tokyo, Japan

Site Status RECRUITING

Takeda Site 12

Yodogawa-ku, Osaka-shi, Ôsaka, Japan

Site Status RECRUITING

Takeda Site 16

Junggu, Daegu Gwang'yeogsi, South Korea

Site Status RECRUITING

Takeda Site 19

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

Takeda Site 21

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Takeda Site 18

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States China France Italy Japan South Korea Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Takeda Contact

Role: CONTACT

[email protected]
+1-877-825-3327

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.takeda.com/study-detail/f4aacba8d8fb4c8f??page=1&idFilter=TAK-360-2001

Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-517711-70-01

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-360-2001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
NCT04091438 COMPLETED PHASE1
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
NCT02512588 COMPLETED PHASE2
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
NCT03267303 COMPLETED PHASE2
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
NCT00655369 COMPLETED PHASE2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
NCT03522506 COMPLETED PHASE1
A Study of LY2624803 in Japanese Participants With Transient Insomnia
NCT01784614 COMPLETED PHASE1
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
NCT01681121 COMPLETED PHASE2
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
NCT01638403 COMPLETED PHASE3
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
NCT05015673 COMPLETED PHASE1
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
NCT01485770 COMPLETED PHASE2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
NCT06752668 RECRUITING PHASE2
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants
NCT04551079 COMPLETED PHASE1
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
NCT02348593 COMPLETED PHASE3
Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia
NCT00656994 COMPLETED PHASE3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
NCT06767683 RECRUITING PHASE2/PHASE3
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
NCT03772314 COMPLETED PHASE2
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
NCT06179407 TERMINATED PHASE1
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
NCT01124851 COMPLETED PHASE1
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
NCT00066170 COMPLETED PHASE3
Late Phase II Study of TS-142 in Patients with Insomnia
NCT04469023 COMPLETED PHASE2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
NCT06843590 RECRUITING PHASE2
Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
NCT00280436 COMPLETED PHASE2
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
NCT01021852 COMPLETED PHASE2
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
NCT04072380 COMPLETED PHASE2
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
NCT00401284 COMPLETED PHASE2