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Recruiting NCT07633301

A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

Phase II Interventional Narcolepsy Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAK-360, Placebo.
Who it may be relevant to
Registry conditions: Narcolepsy Type 1. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, France, Italy +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Overview

Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.

Interventions

  • Drug TAK-360
    TAK-360 tablet
  • Drug Placebo
    TAK-360 matching placebo tablet

Primary outcome measures

  • Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 28 weeks]
Secondary outcome measures (3)
  • Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6 [Time frame: Baseline, Week 6]
  • Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6 [Time frame: Baseline, Week 6]
  • Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6 [Time frame: Week 6]

Eligibility criteria

Inclusion criteria

  • The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive).
  • The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.

Exclusion criteria

  • The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
  • The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
  • The participant has a clinically significant history of head injury or head trauma.
  • The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
  • The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
  • The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor).
  • The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
  • The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004.
  • The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Japan · 5 centers
  • Takeda Site 17 — Fukuoka
  • Takeda Site 1 — Kumamoto
  • Takeda Site 18 — Isahaya-shi
  • Takeda Site 15 — Yodogawa-ku, Osaka-shi
  • Takeda Site 16 — Shinjuku-ku
United States · 3 centers
  • Takeda Site 12 — Redwood City
  • Takeda Site 14 — Miami
  • Takeda Site 13 — Cincinnati
China · 3 centers
  • Takeda Site 4 — Beijing
  • Takeda Site 3 — Guangzhou
  • Takeda Site 5 — Zhengzhou
France · 2 centers
  • Takeda Site 6 — Herault
  • Takeda Site 7 — Paris
Italy · 2 centers
  • Takeda Site 8 — Bologna
  • Takeda Site 9 — Verona
Spain · 2 centers
  • Takeda Site 11 — Barcelona
  • Takeda Site 10 — Madrid
Australia · 1 center
  • Takeda Site 2 — Macquarie Park

Identifiers

NCT: NCT07633301 · TAK-360-2004 · 2025-522587-33-00 · jRCT2031260186

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗