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

NCT07633301 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TAK-360-20042025-522587-33-00
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcolepsy Type 1

Keywords

Drug Therapy; Narcolepsy With Cataplexy; NT1

Outcome Measures

Primary Outcomes (1)

• Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

  Up to approximately 28 weeks

Secondary Outcomes (3)

• Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6

  Baseline, Week 6

• Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6

  Baseline, Week 6

• Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6

  Week 6

Study Arms (5)

Part A: TAK-360

EXPERIMENTAL

Participants will receive TAK-360 tablets, orally.

Drug: TAK-360

Part A: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: TAK-360

EXPERIMENTAL

Participants will receive TAK-360 tablets, orally.

Drug: TAK-360

Part B: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part C

EXPERIMENTAL

Participants will receive TAK-360 tablets, orally.

Drug: TAK-360

Interventions

TAK-360 DRUG

TAK-360 tablet

Part A: TAK-360; Part B: TAK-360; Part C

Placebo DRUG

TAK-360 matching placebo tablet

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Site 1

Kumamoto, Kumamoto, 862-0954, Japan

RECRUITING

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MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): November 28, 2027
• Study Completion (Estimated): November 28, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)