A Phase 2/3 interventional study of TAK-360 and Placebo in Idiopathic Hypersomnia, Narcolepsy Type 1 and Narcolepsy Type 2, sponsored by Takeda. Recruiting at 33 sites in 5 countries. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Takeda · Phase 2/3, Interventional, and Treatment
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.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 500 is above the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
TAK-360 tablets
TAK-360-matching placebo tablets
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.
Time frame: Up to approximately 5 years
All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Time frame: Baseline through Year 5
All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
The MWT evaluates a participant's ability to remain awake under soporific conditions for a defined period. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. One MWT, that includes four 40-minute wake trials, will be done. Sleep latency in each wake trial will be recorded. Participants will be required to stay awake in between the 4 MWT wake trials.
Time frame: Baseline through Month 6
IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score
The IHSS is a 14-item self-assessment questionnaire, to measure the severity, frequency and functional impact of the 3 key IH symptoms (during a recall period of "past 7 days"). The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10 to 14 assess daytime functioning alterations due to hypersomnolence. Six items (1,2,3,5,7,8) are scored with 4 ranged response options, with score from 0 to 3, and 8 items (4,6,9,10,11,12,13,14) with 5 ranged response options, with score from 0 to 4, with 1 additional response option for item 14. The total IHSS score is the sum of all item scores (range: 0 to 50); higher scores indicate more severe symptoms.
Time frame: Baseline through Year 5
NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)
The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disrupted nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 8 items that assess symptoms severity \[2 with 4 response options, 1 response with 6 options, and 5 items capturing event count\], and 7 items that describe the symptom effect on daily life with 4 response options). The presence of narcolepsy symptoms is defined by EDS (score greater than or equal to \[≥\] 1 on at least one of items 1, 2, 3, 4, 5, 6, or 7), cataplexy (score ≥1 on at least one of items 8, 9, or 10), hallucinations (score ≥1 on at least one of items 11 and 12), sleep paralysis (score ≥1 on at least one of the items 13 and 14), and disrupted nighttime sleep by a score ≥1 on item 15. Higher scores indicate greater symptom severity or degree of impact.
Time frame: Baseline through Year 5
NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT)
The NSS-2-CT is a 12-item self-administered questionnaire that assesses the severity and consequences of major narcolepsy symptoms such as daytime sleepiness, hallucinations, sleep paralysis, and disrupted nighttime sleep, with higher scores indicating more severe narcolepsy symptoms and impacts. The total score ranges from 0-44(sum of 6 items that assess event symptom severity \[including 2 items with 4 response options, 1 item with 6 response options, and 3 items capturing event count\], and 6 items that describe symptom effect on daily life, with 4 response options), and differs from the NSS-CT in its omission of cataplexy-related items. The presence of narcolepsy symptoms is defined by EDS (score ≥1 on at least one of items 1, 2, 3, 4, 5, 6, or 7), hallucinations (score ≥1 on at least one of items 8 and 9), sleep paralysis (score ≥1 on at least one of the items 10 and 11), and disrupted nighttime sleep by a score ≥1 on item 12.
Time frame: Baseline, Month 1 through Year 5
Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary
Participants will complete a patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy attacks in the diary. The total number of events averaged for a week will be reported.
Time frame: Baseline, Month 3 through Month 24
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · vivli.org
Started Jun 2026 (actual). Primary completion is estimated for Jun 2031, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: TAK-360