NCT07646678

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

StatusRecruiting

PhasePhase 2/3

SponsorTakeda

Primary completionJun 15, 2031 (estimated)

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Minor Nov 4, 2026 Study sites: 31 to 33
Minor Oct 26, 2026 Trial sites expanded: 24 → 31 locations
Notable Sep 17, 2026 Eligibility criteria expanded, about 13 words
- Trial sites expanded: 13 → 24 locations
- Secondary endpoints: details revised at 6 of 6 entries
Minor Aug 20, 2026 Trial sites expanded: 1 → 13 locationsv5
Minor Jul 14, 2026 Secondary endpoints: details revised at 3 of 6 entriesv3
Notable Jun 25, 2026 Recruitment opened
- Study sites: 0 to 1
- Start date changed from estimate of Jun 10, 2026 to Jun 11, 2026
v2
Jun 9, 2026 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

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

Timeframe: Up to approximately 5 years

Secondary (6)

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

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

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

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

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

Show 1 moreShow less

Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary

Arms and interventions

TAK-360 Long Term Extension (LTE) PhaseExperimental

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.

Drugs: TAK-360, Placebo

Sites

33 sites in 5 countries

United States 22, Japan 6, China 3, Australia 1, South Korea 1

About this trial

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.

Trial details

Enrollment: 500 participants (estimated)
Started: Jun 11, 2026
Study completion: Jun 15, 2031 (estimated)
Eligibility: 18 to 71, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
Official title: A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions
First posted: Jun 15, 2026
Registry updated: Nov 5, 2026
Last verified: Nov 2026

Related trials at risk

View on ClinicalTrials.gov ↗