A Phase 2 interventional study of TAK-360 and Placebo in Narcolepsy Type 1, sponsored by Takeda. Recruiting at 18 sites in 7 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 92 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive TAK-360 tablets, orally.
Drug: TAK-360
Participants will receive TAK-360 matching placebo tablets, orally.
Drug: Placebo
Participants will receive TAK-360 tablets, orally.
Drug: TAK-360
Participants will receive TAK-360 matching placebo tablets, orally.
Drug: Placebo
Participants will receive TAK-360 tablets, orally.
Drug: TAK-360
TAK-360 tablet
TAK-360 matching placebo tablet
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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 28 weeks
Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep.
Time frame: Baseline, Week 6
Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
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 reference range.
Time frame: Baseline, Week 6
Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
Time frame: Week 6
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
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Studies of the drug tested here: TAK-360