A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia

NCT07646678 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TAK-360-20032025-522833-68-00
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps. The study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety). Participants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing. The participants will have to visit the clinic multiple times during this study.

Conditions

Idiopathic Hypersomnia; Narcolepsy Type 1; Narcolepsy Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)

  An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. 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 5 years

Secondary Outcomes (6)

• All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score

  Baseline through Year 5

• All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)

  Baseline through Month 6

• IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score

  Baseline through Year 5

• NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)

  Baseline through Year 5

• NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT)

  Baseline, Month 1 through Year 5

Study Arms (1)

TAK-360 Long Term Extension (LTE) Phase

EXPERIMENTAL

Participants will receive one of the available TAK-360 doses for up to approximately 5 years in this trial. Participants will enter the LTE on the dose they were in the parent trial or for participants with discontinued dosing regimen in the parent trial to the next closest available dose/dosing regimen for their indication in this trial. Participants rolling over to this trial from a placebo arm in the parent trial, will receive one of the available TAK-360 doses. Placebo will be only administered as needed to maintain dose blinding between TAK-360 doses and regimens.

Drug: TAK-360; Drug: Placebo

Interventions

TAK-360 DRUG

TAK-360 tablets

TAK-360 Long Term Extension (LTE) Phase

Placebo DRUG

TAK-360-matching placebo tablets

TAK-360 Long Term Extension (LTE) Phase

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to understand and fully comply with trial procedures and requirements.
• Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
• Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.

You may not qualify if:

• Participant has a positive pregnancy test or is lactating/breastfeeding.
• Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
• Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• Participant has developed a new history of seizures.
• Participant has experienced clinically significant head injury, per investigator opinion.
• Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \[\<\] 5 years ago), or cerebral haemorrhage.
• Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
• The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
• Participant has developed a history of cancer in the past 5 years.

Sponsors & Collaborators

• Takeda: lead

Related Links

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MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

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

Study Officials

• Takeda Contact

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 15, 2031
• Study Completion (Estimated): June 15, 2031
• Last Updated: June 15, 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.