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

Conditions

• Idiopathic Hypersomnia
• Narcolepsy Type 1
• Narcolepsy Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 71 Years

Healthy Volunteers

Not accepted

Interventions

• TAK-360 — DRUG
  TAK-360 tablets
• Placebo — DRUG
  TAK-360-matching placebo tablets

Study Details

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.

Key Dates

First listed

Jun 15, 2026

Start date

Jun 11, 2026

Status verified

Aug 2026

Primary completion

Jun 15, 2031

Completion

Jun 15, 2031

Study Design

Enrollment

500 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Study Director
  +1-877-825-3327
  [email protected]

Locations (9)

Find similar trials in Brandon, FL

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