Recruiting

Phase 2

Phase 3

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

Sponsor:

Takeda

Code:

NCT07646678

Conditions

Idiopathic Hypersomnia

Narcolepsy Type 1

Narcolepsy Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TAK-360

Placebo

Study Details

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

Study ID

NCT07646678

Start date

Jun 11, 2026

Status verified date

Sep, 2026

Completion date

Jun 15, 2031

Anticipated

Primary completion date

Jun 15, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Participant is willing and able to understand and fully comply with trial procedures and requirements.
2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
3. 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.

Key Exclusion Criteria:

1. Participant has a positive pregnancy test or is lactating/breastfeeding.
2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
5. Participant has developed a new history of seizures.
6. Participant has experienced clinically significant head injury, per investigator opinion.
7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \[<\] 5 years ago), or cerebral haemorrhage.
8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
9. 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.
10. Participant has developed a history of cancer in the past 5 years.

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-360 Long Term Extension (LTE) Phase

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.

Interventions

TAK-360

TAK-360 tablets

Placebo

TAK-360-matching placebo tablets

Primary outcome measure

Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Study Director

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

Locations

Takeda Site 23

Recruiting

Chula Vista, California, United States, 91910

Takeda Site 14

Recruiting

Colorado Springs, Colorado, United States, 80918

Takeda Site 11

Recruiting

Brandon, Florida, United States, 33511

Takeda Site 7

Recruiting

Miami, Florida, United States, 33176

Takeda Site 18

Recruiting

Winter Park, Florida, United States, 32789

Takeda Site 6

Recruiting

Atlanta, Georgia, United States, 30328

Takeda Site 21

Recruiting

Southfield, Michigan, United States, 48075

Takeda Site 9

Recruiting

St Louis, Missouri, United States, 63123

Takeda Site 19

Recruiting

Middletown, New Jersey, United States, 07748

Takeda Site 24

Recruiting

Denver, North Carolina, United States, 28037

Takeda Site 10

Recruiting

Huntersville, North Carolina, United States, 28078

Takeda Site 22

Recruiting

Winston-Salem, North Carolina, United States, 27103

Takeda Site 2

Recruiting

Cincinnati, Ohio, United States, 45245

Takeda Site 4

Recruiting

Cincinnati, Ohio, United States, 45245

Takeda Site 8

Recruiting

Columbia, South Carolina, United States, 29021

Takeda Site 20

Recruiting

Austin, Texas, United States, 78731

Takeda Site 3

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Takeda

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

Drug Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.